Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic.

INTRODUCTION: Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research. METHODS: The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings. RESULTS: During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public. CONCLUSION: The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.

Perioperative Complications in Patients with Systemic Sclerosis: A Comparative Cohort Analysis.

Background: Systemic sclerosis (SSc) is a rare autoimmune disorder with pathological manifestations affecting multiple organ systems. Few studies have examined perioperative outcomes in patients with this disorder. The primary aim of this retrospective single-center comparative cohort analysis was to estimate the incidence of select perioperative complications in a population of SSc patients. In an exploratory analysis, we analyzed the relationship between SSc and susceptibility to select perioperative complications when treated at a large quaternary-care institution. Methods: We conducted a single-center retrospective, comparative cohort study to compare perioperative outcomes in a SSc (n=258) and a frequency matched control cohort (n=632). We analyzed for the presence of major composite infection (MCI), major adverse cardiac events (MACE), 30-day readmission, 30-day mortality, in-hospital complications, length of stay and airway management outcomes. Results: MCI was higher in the SSc compared to the control cohort [adjusted odds ratio (ORadj)=5.02 (95%CI: 2.47-10.20) p<0.001]. Surgical site infection (3.5% vs. 0%, p<0.001), and other infection types (5% vs. 0%, p<0.001) were higher in the SSc cohort. MACE was not significantly different between SSc vs. Control groups [6.2% vs. 7.9%, ORadj=1.33 (95%CI: 0.61-2.91) p=0.48]. Higher rates of limited cervical range of motion (13.6% vs. 3.5%, p<0.001), microstomia (11.5% vs. 1.3%, p<0.001) and preoperative difficult airway designation (8.7% vs. 0.5%, p<0.001) were observed in the SSc cohort. Bag mask ventilation grade was similar between groups (p=0.44). After adjustment, there was no between-group difference in Cormack-Lehane grade 3 and 4 view on direct laryngoscopy in SSc patients [ORadj = 1.86 (95%CI: 0.612 -5.66) p=0.18] but evidence of higher rates of video laryngoscopy [ORadj= 1.87 (95%CI:1.07 - 3.27) p=0.03]. Length of stay [median: 0.2 vs. 0.3 days, p=0.08], 30-day mortality [1.2% vs. 0.6%, ORadj=2.79 (95%CI: 0.50-15.6) p=0.24] and readmission [11.5% vs. 8.1%, ORadj=1.64 (95%CI: 0.96 - 2.82) p=0.07] were not statistically significant. Conclusions: SSc patients demonstrate mostly similar rates of MACE, 30-day mortality, length of stay intraoperative and airway complications. There is evidence of increased risk of overall 30-day MCI risk and readmission after endoscopic procedures.

Comparison of electronic versus phone-based administration of the Quality of Recovery-40 survey after ambulatory surgery.

STUDY OBJECTIVE: Studies that track patient-centered outcomes are better suited to evaluate the relative benefits and harms of an intervention in ambulatory surgery as severe morbidity and mortality have become increasingly rare. This pilot study aimed to assess for differences in response rate and survey scores for phone-based and electronic administration of the Quality of Recovery-40 (QoR-40) survey in patients undergoing general anesthesia for ambulatory surgery. DESIGN: A single-center prospective observational study. SETTING: Yale New Haven Hospital (September 22-November 2, 2021). PATIENTS: 100 consecutive patients undergoing ambulatory surgery under general anesthesia. INTERVENTIONS: Patients were randomized to receive QoR-40 surveys via email or phone. MEASUREMENTS: The QoR-40 survey is a 40-item questionnaire that provides a global score across five dimensions: patient support, comfort, emotions, physical independence, and pain. The primary outcome was the response rate following the administration of the QoR-40 survey on postoperative days 1, 2, and 7. The secondary outcome was the mean QoR-40 score during the study period. MAIN RESULTS: A total of 109 patients consented to participate and 100 patients were randomized in this study. A total of 76%, 72%, and 68% of patients completed the survey on POD 1, 2, and 7, respectively. There were no differences in the response rate of patients who completed the survey between phone (78%) versus electronic (74%) administration (difference 4%, 95% confidence interval (CI): -13%, 21%, respectively) on POD 1, 2 (74% vs 70%, difference 4%, 95% CI -14%, 22%, respectively) or 7 (68% vs 68%, difference 0%, 95% CI -18%, 18%, respectively). The mean (standard deviation) QoR-40 score was 176.2 (18.1), 179.8 (19.4), 187.7 (13.1) on POD 1, 2, and 7, respectively. There were no significant differences in the mean QoR-40 scores between groups at any of the time points. CONCLUSION: The response rate following the electronic administration of the QoR-40 survey did not differ from the phone-based administration during the postoperative period following ambulatory surgery. The use of an electronic version of the survey may allow for larger sample sizes with fewer resources utilized in future interventional studies.

Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery.

BACKGROUND: Intraperitoneal chloroprocaine has been used during cesarean delivery to supplement suboptimal neuraxial anesthesia for decades. The short in vitro half-life of chloroprocaine (11-21 seconds) has been cited to support the safety of this approach. However, there are no data regarding the rate of absorption, representing patient drug exposure, through this route of administration. Accordingly, we designed a study to determine the in vivo half-life of intraperitoneal chloroprocaine and assess clinical tolerability. METHODS: We designed a single-center, prospective, cohort, multiple-dose escalation study of women 18 to 50 years of age undergoing cesarean delivery with spinal anesthesia. Chloroprocaine (40 mL) was administered after delivery of the newborn and before uterine closure. The first cohort (n = 5) received 1%, the second cohort (n = 5) received 2%, and the third cohort (n = 5) received 3% chloroprocaine solution. Maternal blood samples were obtained before administration and 1, 5, 10, 20, and 30 minutes after dosing. The primary objective was to define the pharmacokinetic profile of intraperitoneal chloroprocaine, including in vivo half-life. The secondary objective was to evaluate tolerability through determination of peak plasma concentration and prospective assessment for local anesthetic systemic toxicity. RESULTS: The peak plasma concentration occurred 5 minutes after intraperitoneal administration in all 3 cohorts: 64.8 ng/mL (6.5 µg/kg), 28.7 ng/mL (2.9 µg/kg), and 799.2 ng/mL (79.9 µg/kg) for 1%, 2%, and 3% chloroprocaine, respectively. The in vivo half-life of chloroprocaine after intraperitoneal administration was estimated to be 5.3 minutes (95% confidence interval, 4.0-6.6). We did not detect clinical signs of local anesthetic systemic toxicity in any of the 3 cohorts. CONCLUSIONS: The in vivo half-life of intraperitoneal chloroprocaine (5.3 minutes) is more than an order of magnitude greater than the in vitro half-life (11-21 seconds). However, maximum plasma concentrations of chloroprocaine (C max range, 0.05-79.9 µg/kg) were not associated with local anesthetic systemic toxicity and remain well below our predefined safe level of exposure (970 µg/kg) and levels associated with clinical symptoms (2.6-2.9 mg/kg). Therefore, our study suggests that intraperitoneal chloroprocaine, in a dosage ≤1200 mg, administered after fetal extraction, is well tolerated during cesarean delivery.

A Decision Tree Approach to Airway Management Pathways in the 2022 Difficult Airway Algorithm of the American Society of Anesthesiologists.

The American Society of Anesthesiologists' (ASA) Task Force on Management of the Difficult Airway has developed a decision tree tool that uses inductive assessments to guide the anesthesiologist's choice of pathway in the ASA's Difficult Airway Algorithm. The tool prompts the anesthesiologist to consider the risk of difficulty with laryngoscopy (direct or indirect) and tracheal intubation, facemask or supraglottic ventilation, gastric contents aspiration, and rapid oxyhemoglobin desaturation. For every airway management event, the approach integrates the anesthesiologist's unique combination of experience, expertise, patient anatomy and disease, equipment availability, and other contextual conditions into the decision process. Entry into the awake intubation pathway is encouraged when the patient is judged at risk of difficult tracheal intubation and one or more of the following: difficult ventilation, significant aspiration risk, and/or rapid oxyhemoglobin desaturation. The decision tree tool is anticipated to improve communication between anesthesiologists and others by clearly identifying those factors of concern and how decision-making is affected by those concerns.

Ultrasound Image Quality Comparison Between a Handheld Ultrasound Transducer and Mid-Range Ultrasound Machine.

Objectives: Not all labor and delivery floors are equipped with ultrasound machines which can serve the needs of both obstetricians and anesthesiologists. This cross-sectional, blinded, randomized observational study compares the image resolution (RES), detail (DET), and quality (IQ) acquired by a handheld ultrasound, the Butterfly iQ, and a mid-range mobile device, the Sonosite M-turbo US (SU), to evaluate their use as a shared resource. Methods: Seventy-four pairs of ultrasound images were obtained for different imaging purposes: 29 for spine (Sp), 15 for transversus abdominis plane (TAP) and 30 for diagnostic obstetrics (OB) purposes. Each location was scanned by both the handheld and mid-range machine, resulting in 148 images. The images were graded by three blinded experienced sonographers on a 10-point Likert scale. Results: The mean difference for Sp imaging favored the handheld device (RES: -0.6 [(95% CI -1.1, -0.1), p = 0.017], DET: -0.8 [(95% CI -1.2, -0.3), p = 0.001] and IQ: -0.9 [95% CI-1.3, -0.4, p = 0.001]). For the TAP images, there was no statistical difference in RES or IQ, but DET was favored in the handheld device (-0.8 [(95% CI-1.2, -0.5), p < 0.001]). For OB images, the SU was favored over the handheld device with RES, DET and IQ with mean differences of 1.7 [(95% CI 1.2, 2.1), p < 0.001], 1.6 [(95% CI 1.2, 2.0], p < 0.001] and 1.1 [(95% CI 0.7, 1.5]), p < 0.001), respectively. Conclusions: Where resources are limited, a handheld ultrasound may be considered as a potential low-cost alternative to a more expensive ultrasound machine for point of care ultrasonography, better suited to anesthetic vs. diagnostic obstetrical indications.

Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention.

OBJECTIVE: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system. DESIGN: Randomized controlled trial with masked outcome assessment. SETTING: Five Veterans Affairs medical centers geographically dispersed across the United States. PARTICIPANTS: 147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147). INTERVENTIONS: Participants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested. MAIN OUTCOME MEASURES: Primary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up). RESULTS: Participants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=-0.61; 95% confidence interval, -1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high. CONCLUSIONS: Group-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied.

Agreement Between the Mini-Cog in the Preoperative Clinic and on the Day of Surgery and Association With Postanesthesia Care Unit Delirium: A Cohort Study of Cognitive Screening in Older Adults.

BACKGROUND: Cognitive impairment is common in older surgical patients and is associated with postoperative delirium. However, cognitive function is inconsistently assessed preoperatively, leading to missed opportunities to recognize vulnerable patients. We designed a prospective cohort study to assess the agreement of the Mini-Cog screening tool administered in the preoperative clinic (clinic-day test) or immediately before surgery (surgery-day test) and to determine whether a positive screening for cognitive dysfunction in the surgery-day test is associated with postoperative delirium in the postanesthesia care unit (PACU). METHODS: This was a cohort study of patients aged 65-89 years, scheduled for elective, inpatient surgery under general anesthesia between June 20, 2018 and August 3, 2018. Mini-Cog test scores were obtained during a clinic-day test and surgery-day test. The Short Confusion Assessment Method was performed in the PACU. Agreement between Mini-Cog clinic-day and surgery-day test scores was estimated using an ordinally weighted kappa statistic, κ. Multivariable logistic regression was used to determine whether there was an association between a positive screen for cognitive impairment and PACU delirium. Odds ratio analysis was performed to determine whether the Mini-Cog score was associated with PACU delirium. RESULTS: Of 128 patients meeting eligibility criteria, 80 patients were enrolled. Ten had cognitive impairment based on the Mini-Cog clinic-day test score, while 70 did not. Age, sex, race, education level, subjective memory impairment, and American Society of Anesthesiologists (ASA) physical status were equivalent in the 2 groups. The mean number of days between the clinic-day score and the surgery-day score was 8.4 days (standard deviation [SD] = 6.9). Mini-Cog clinic-day and surgery-day scores had high agreement (κ = 0.78; 95% confidence interval [CI], 0.69-0.87; P < .001), and both scores were highly predictive of PACU delirium. Patients with Mini-Cog surgery-day scores compatible with cognitive impairment (Mini-Cog scores ≤2) had an estimated 12.8 times higher odds of PACU delirium compared to patients with normal cognitive function or Mini-Cog scores >2 (odds ratio [OR] = 12.8; 95% CI, 2.6-63.8, P = .002). Similarly, patients with Mini-Cog clinic-day test scores compatible with cognitive impairment had an estimated 29 times higher odds of PACU delirium compared to patients with normal cognitive function (OR = 29.0; 95% CI, 2.6-63.8, P < .001). CONCLUSIONS: These data support the approach of using the Mini-Cog on the day of surgery to screen for cognitive impairment in older patients. Importantly, Mini-Cog surgery-day test scores compatible with cognitive impairment (≤2) were strongly associated with PACU delirium.

Genetic and pharmacological relationship between P-glycoprotein and increased cardiovascular risk associated with clarithromycin prescription: An epidemiological and genomic population-based cohort study in Scotland, UK.

BACKGROUND: There are conflicting reports regarding the association of the macrolide antibiotic clarithromycin with cardiovascular (CV) events. A possible explanation may be that this risk is partly mediated through drug-drug interactions and only evident in at-risk populations. To the best of our knowledge, no studies have examined whether this association might be mediated via P-glycoprotein (P-gp), a major pathway for clarithromycin metabolism. The aim of this study was to examine CV risk following prescription of clarithromycin versus amoxicillin and in particular, the association with P-gp, a major pathway for clarithromycin metabolism. METHODS AND FINDINGS: We conducted an observational cohort study of patients prescribed clarithromycin or amoxicillin in the community in Tayside, Scotland (population approximately 400,000) between 1 January 2004 and 31 December 2014 and a genomic observational cohort study evaluating genotyped patients from the Genetics of Diabetes Audit and Research Tayside Scotland (GoDARTS) study, a longitudinal cohort study of 18,306 individuals with and without type 2 diabetes recruited between 1 December 1988 and 31 December 2015. Two single-nucleotide polymorphisms associated with P-gp activity were evaluated (rs1045642 and rs1128503 -AA genotype associated with lowest P-gp activity). The primary outcome for both analyses was CV hospitalization following prescription of clarithromycin versus amoxicillin at 0-14 days, 15-30 days, and 30 days to 1 year. In the observational cohort study, we calculated hazard ratios (HRs) adjusted for likelihood of receiving clarithromycin using inverse proportion of treatment weighting as a covariate, whereas in the pharmacogenomic study, HRs were adjusted for age, sex, history of myocardial infarction, and history of chronic obstructive pulmonary disease. The observational cohort study included 48,026 individuals with 205,227 discrete antibiotic prescribing episodes (34,074 clarithromycin, mean age 73 years, 42% male; 171,153 amoxicillin, mean age 74 years, 45% male). Clarithromycin use was significantly associated with increased risk of CV hospitalization compared with amoxicillin at both 0-14 days (HR 1.31; 95% CI 1.17-1.46, p < 0.001) and 30 days to 1 year (HR 1.13; 95% CI 1.06-1.19, p < 0.001), with the association at 0-14 days modified by use of P-gp inhibitors or substrates (interaction p-value: 0.029). In the pharmacogenomic study (13,544 individuals with 44,618 discrete prescribing episodes [37,497 amoxicillin, mean age 63 years, 56% male; 7,121 clarithromycin, mean age 66 years, 47% male]), when prescribed clarithromycin, individuals with genetically determined lower P-gp activity had a significantly increased risk of CV hospitalization at 30 days to 1 year compared with heterozygotes or those homozygous for the non-P-gp-lowering allele (rs1045642 AA: HR 1.39, 95% CI 1.20-1.60, p < 0.001, GG/GA: HR 0.99, 95% CI 0.89-1.10, p = 0.85, interaction p-value < 0.001 and rs1128503 AA 1.41, 95% CI 1.18-1.70, p < 0.001, GG/GA: HR 1.04, 95% CI 0.95-1.14, p = 0.43, interaction p-value < 0.001). The main limitation of our study is its observational nature, meaning that we are unable to definitively determine causality. CONCLUSIONS: In this study, we observed that the increased risk of CV events with clarithromycin compared with amoxicillin was associated with an interaction with P-glycoprotein.

COVID-19 mortality risk for older men and women.

BACKGROUND: Case-fatality from COVID-19 has been reported to be relatively high in patients age 65 years or older. We sought to determine the age-specific rates of COVID-19 mortality at the population level. METHODS: We obtained information regarding the total number of COVID-19 reported deaths for six consecutive weeks beginning at the 50th recorded death, among 16 countries that reported a relatively high number of COVID-19 cases as of April 12, 2020. We performed an ecological study to model COVID-19 mortality rates per week by age group (54 years or younger, 55-64 years, and 65 years or older) and sex using a Poisson mixed effects regression model. RESULTS: Over the six-week period of data, there were 178,568 COVID-19 deaths from a total population of approximately 2.4 billion people. Age and sex were associated with COVID-19 mortality. Compared with individuals ages 54 years or younger, the incident rate ratio (IRR) was 8.1, indicating that the mortality rate of COVID-19 was 8.1 times higher (95%CI = 7.7, 8.5) among those 55 to 64 years, and more than 62 times higher (IRR = 62.1; 95%CI = 59.7, 64.7) among those ages 65 or older. Mortality rates from COVID-19 were 77% higher in men than in women (IRR = 1.77, 95%CI = 1.74, 1.79). CONCLUSIONS: In the 16 countries examined, persons age 65 years or older had strikingly higher COVID-19 mortality rates compared to younger individuals, and men had a higher risk of COVID-19 death than women.

Implementation of the TaperGuard™ endotracheal tube in an unselected surgical population to reduce postoperative pneumonia.

BACKGROUND: Endotracheal tube (ETT) designs to decrease the risk of ventilator associated pneumonia (VAP) include supraglottic suctioning, and/or modifications of the cuff shape. The TaperGuard™ ETT has a tapered, polyvinylchloride cuff designed to reduce microaspiration around channels that form with a standard barrel-shaped cuff. We compared risk of postoperative pneumonia using the TaperGuard™ ETT and the standard ETT in surgical patients requiring general anesthesia with endotracheal intubation. METHODS: We used an interrupted time-series design to compare endotracheal intubation using the TaperGuard™ ETT (intervention cohort), and a historic cohort using the standard ETT (baseline cohort), among surgical patients requiring hospital admission. We compared the incidence of postoperative pneumonia in the intervention and baseline cohorts. Data were collected from the electronic health record and linked to patient-level data from National Surgical Quality Improvement Project. Additionally, we performed secondary analyses in a subgroup of patients at high risk of postoperative pneumonia. RESULTS: 15,388 subjects were included; 6351 in the intervention cohort and 9037 in the baseline cohort. There was no significant difference in the incidence of postoperative pneumonia between the intervention cohort (1.62%) and the baseline cohort (1.79%). The unadjusted odds ratio (OR) of postoperative pneumonia was 0.90 (95% CI: 0.70, 1.16; p = 0.423) and the OR adjusted for patient characteristics and potential confounders was 0.90 (95% CI: 0.69, 1.19; p = 0.469), comparing the intervention and baseline cohorts. There was no a priori selected subgroup of patients for whom the use of the TaperGuard™ ETT was associated with decreased odds of postoperative pneumonia relative to the standard ETT. Hospital mortality was higher in the intervention cohort (1.5%) compared with the baseline cohort (1.0%; OR 1.46, 95% CI: 1.09, 1.95; p = 0.010). CONCLUSIONS: The broad implementation of the use of the TaperGuard™ ETT for intubation of surgical patients was not associated with a reduction in the risk of postoperative pneumonia. In the setting of a low underlying postoperative pneumonia risk and the use of recommended preventative VAP bundles, further risk reduction may not be achievable by simply modifying the ETT cuff design in unselected or high-risk populations undergoing inpatient surgery. TRIAL REGISTRATION: ClinicalTrials.gov, ID NCT02450929 .

Oropharyngeal Oxygen Concentration Is Dependent on the Oxygen Mask System and Sampling Location.

BACKGROUND: Numerous oxygen delivery systems are used to treat hypoxemia. It is unknown if FIO2 at the lips predicts oropharyngeal FIO2 for various oxygen mask systems. We tested whether FIO2 measurements differed between the lips and oropharynx, and whether this difference depends on the mask system. METHODS: Ten healthy volunteers had one sampling catheter positioned at the lips and another catheter in the oropharynx. FIO2 was sampled at each location while the subjects breathed normal tidal volumes with oxygen at 15 L/min via 4 delivery devices: a simple mask, a non-rebreather mask, a face mask with a diffuser that concentrates and directs O2 toward the mouth and nose (mask with diffuser), and a closed mask with a Jackson-Rees circuit. Data were analyzed by using a linear mixed model to account for subject crossover in the repeated measures design. RESULTS: FIO2 levels differed significantly for the 4 delivery mask systems (P < .001) and by sampling catheter location (P < .001). Differences in mean FIO2 between the lips and the oropharynx were observed for the mask with diffuser (difference 0.30, 95% CI 0.25-0.36; P < .001), and non-rebreather mask (difference 0.09, 95% CI 0.04-0.15; P = .001). The mean FIO2 at the oropharynx was highest for the closed mask (0.97, 95% CI 0.92-1.00), followed by the non-rebreather mask (0.76, 95% CI 0.72-0.81), simple mask (0.62, 95% CI 0.58-0.67), and the mask with diffuser (0.51, 95% CI 0.46-0.56). At the lips, the mean FIO2 was highest for the closed mask (0.97, 95% CI 0.92-1.00), followed by the non-rebreather mask (0.86, 95% CI 0.81- 0.90), OxyMask (0.81, 95% CI 0.76-0.86), and simple mask (0.67, 95% CI 0.62-0.71). CONCLUSIONS: With high oxygen flows and normal tidal volume breathing, FIO2 measurements obtained at the oropharynx or at the lips depended on the device used, with the mask with diffuser showing the most significant discrepancies. FIO2 measures at the oropharynx and the lips were only consistent for the closed mask system. (ClinicalTrials.gov registration NCT02523586.).

Randomized controlled trial of acupuncture to prevent emergence delirium in children undergoing myringotomy tube placement.

BACKGROUND: Myringotomy tube placement is a pediatric procedure frequently performed under inhalational anesthesia without intravenous line placement. Emergence delirium is common following sevoflurane anesthesia, and can lead to patient harm and escalation of nursing care. Our goal was to determine if intraoperative acupuncture, compared to standard of care, reduces emergence delirium in children undergoing myringotomy tube placement. METHODS: Single center, randomized, controlled trial at a university hospital, including children ages 1-6 years with ASA physical status 1-3 scheduled for myringotomy tube placement. Participants were stratified based on midazolam premedication and randomized to intraoperative acupuncture (AC, N.=49) or standard anesthesia care (SC, N.=50). Acupuncture needles were placed in bilateral Heart 7 (HT7) and ear Shen Men points after anesthesia induction. A blinded observer in the PACU assessed emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Endpoints were highest PAED score in the recovery room and post-discharge agitation and sleep quality. RESULTS: Patient baseline characteristics were similar between treatment groups. With midazolam premedication, the highest PAED score was 11.6 in patients receiving AC and 12.0 for SC. Without midazolam premedication, the highest PAED was 11.8 in patients receiving AC and 10.7 for SC. The overall PAED score difference between AC and SC groups was 0.33 (95% CI -1.5, 2.2, P=0.723). CONCLUSIONS: Intraoperative acupuncture at HT7 and ear Shen Men did not reduce PAED scores after myringotomy tube placement. Based on these data, it is therefore unlikely that a larger study of the same design would demonstrate a significant effect of intraoperative acupuncture on emergence delirium after brief sevoflurane anesthesia. However, other acupuncture points or techniques could be considered.

Education Program Regarding Labor Epidurals Increases Utilization by Hispanic Medicaid Beneficiaries: A Randomized Controlled Trial.

BACKGROUND: Hispanic women choose epidural labor analgesia less commonly than non-Hispanic women. This may represent a healthcare disparity related to a language barrier and inadequate opportunities for labor analgesia education. It was hypothesized that a language-concordant, educational program regarding labor epidurals would improve epidural utilization in two independent cohorts of Hispanic and non-Hispanic women. METHODS: A randomized controlled trial, blinded to anesthesia, nursing, and obstetric providers, was completed at an academic hospital (February 2015 to February 2017). Two cohorts of Medicaid beneficiaries of Hispanic (English- and/or Spanish-speaking) and non-Hispanic ethnicity were enrolled concurrently. The patients were randomized to routine care alone or routine care and an additional educational program comprised of three components: a video show, corresponding pamphlet, and in-person counseling. The primary endpoint was use of epidural labor analgesia. The secondary endpoint was change in response before and after delivery on common misconceptions based on a 12-point epidural questionnaire. RESULTS: Hispanic women randomized to the intervention group were 33% more likely to choose epidural analgesia compared to the routine care group (40 of 50 [80%] vs. 30 of 50 [60%]; risk ratio, 1.33 [95% CI, 1.02 to 1.74]; P = 0.029). For the non-Hispanic cohort, no difference was detected in epidural use between the intervention and routine care groups (41 of 50 [82%] vs. 42 of 49 [86%]; risk ratio, 0.96 [95% CI, 0.80 to 1.14]; P = 0.62), but the study was underpowered to determine a result of no difference. Patients assigned to the intervention had a greater improvement in epidural understanding compared with routine care, among both Hispanic (2.26 vs. 0.74, respectively; difference in change from baseline, 1.52 [95% CI, 0.77 to 2.27]; P < 0.001) and non-Hispanic (1.36 vs. 0.33, respectively; difference in change from baseline, 1.03 [95% CI, 0.23 to 1.75]; P = 0.005) cohorts. There were no adverse events during the trial. CONCLUSIONS: The educational program increased epidural use among Hispanic women. The educational program reduced misconceptions regarding epidural analgesia in both Hispanic and non-Hispanic cohorts.

Long-term outcomes among injured older adults transported by emergency medical services.

INTRODUCTION/OBJECTIVE: Little is known about the long-term outcomes of injured older adults cared for in trauma systems. We sought to describe mortality and causes of death over time, and the independent association of injury severity, comorbidities, and other factors on 12-month mortality among injured older adults transported by emergency medical services (EMS). MATERIALS AND METHODS: This was a population-based cohort study of injured adults ≥ 65 years in the United States transported by 44 EMS agencies to 51 hospitals from January 1, 2011 to December 31, 2011, with 12-month follow-up through December 31, 2012. The primary outcomes were time to death and causes of death. We used descriptive statistics and Cox proportional hazards models to generate adjusted hazard ratios (HR). RESULTS: 15,649 injured older adults were transported by EMS, frequently after a fall (84.5%). Serious injuries (Injury Severity Score [ISS] ≥ 16) occurred in 3.5%, with serious extremity injury (Abbreviated Injury Scale score ≥ 3) being most common (17.8%). Mortality rates were: 1.6% in-hospital, 5.1% at 30 days, 9.4% at 90 days and 20.3% at 1 year. The adjusted HR for patients in the highest comorbidity quartile was 2.20 (versus lowest quartile, 95% CI 1.97-2.46, p < .001), while the HR for ISS ≥ 25 was 2.69 (versus ISS 0-8, 95% CI 1.60-4.51, p = .001). Cardiovascular etiologies (53.3%) and dementia (32.7%) were the most common causes of death, with injury listed in 12.8% of death certificates. CONCLUSIONS: Injury requiring EMS transport is a sentinel event among older adults, with death typically occurring months later, often due to cardiovascular causes and dementia. A heavy comorbidity burden had an adjusted mortality risk comparable to severe injury.

Pericyte constriction underlies capillary derecruitment during hyperemia in the setting of arterial stenosis.

Capillary derecruitment distal to a coronary stenosis is implicated as the mechanism of reversible perfusion defect and potential myocardial ischemia during coronary hyperemia; however, the underlying mechanisms are not defined. We tested whether pericyte constriction underlies capillary derecruitment during hyperemia under conditions of stenosis. In vivo two-photon microscopy (2PM) and optical microangiography (OMAG) were used to measure hyperemia-induced changes in capillary diameter and perfusion in wild-type and pericyte-depleted mice with femoral artery stenosis. OMAG demonstrated that hyperemic challenge under stenosis produced capillary derecruitment associated with decreased RBC flux. 2PM demonstrated that hyperemia under control conditions induces 26 ± 5% of capillaries to dilate and 19 ± 3% to constrict. After stenosis, the proportion of capillaries dilating to hyperemia decreased to 14 ± 4% (P = 0.05), whereas proportion of constricting capillaries increased to 32 ± 4% (P = 0.05). Hyperemia-induced changes in capillary diameter occurred preferentially in capillary segments invested with pericytes. In a transgenic mouse model featuring partial pericyte depletion, only 14 ± 3% of capillaries constricted to hyperemic challenge after stenosis, a significant reduction from 33 ± 4% in wild-type littermate controls (P = 0.04). These results provide for the first time direct visualization of hyperemia-induced capillary derecruitment distal to arterial stenosis and demonstrate that pericyte constriction underlies this phenomenon in vivo. These results could have important therapeutic implications in the treatment of exercise-induced ischemia. NEW & NOTEWORTHY In the setting of coronary arterial stenosis, hyperemia produces a reversible perfusion defect resulting from capillary derecruitment that is believed to underlie cardiac ischemia under hyperemic conditions. We use optical microangiography and in vivo two-photon microscopy to visualize capillary derecruitment distal to a femoral arterial stenosis with cellular resolution. We demonstrate that capillary constriction in response to hyperemia in the setting of stenosis is dependent on pericytes, contractile mural cells investing the microcirculation.

Inhaled Iloprost Versus Epoprostenol in Heart Transplant Recipients.

BACKGROUND: Acute right ventricular dysfunction is a challenging problem in the immediate postoperative period following orthotopic heart transplantation. There are no prior reports of the use of inhaled iloprost in the setting of acute right ventricular dysfunction and acute pulmonary hypertension. Our hypothesis was that the use of inhaled iloprost in heart transplant recipients would be associated with a reduction in the duration of mechanical ventilation compared to patients being treated with continuous inhaled epoprostenol. Additionally, we hypothesized that the change in inhaled vasodilatory therapy would not be associated with a significant change in postoperative bleeding or use of vasoactive medications. METHODS: We reviewed charts of 80 consecutive patients undergoing heart transplantation at our institution between July 1, 2003, and August 8, 2008. From July 1, 2003 to March 13, 2006, epoprostenol was our primary vasodilator; subsequently epoprostenol was replaced with iloprost. We included 39 subjects who received epoprostenol and 40 subjects who received iloprost. Data were collected on the use of inhaled vasodilators, comparing periods before and after our institutional protocol change. Demographic data, hemodynamic values, drain output, and any requirement for vasoactive medication infusions were collected. Our primary end point was the natural logarithm of duration of mechanical ventilation. Secondary end points were hemodynamic values and length of ICU and hospital stay. RESULTS: Subjects treated with iloprost were mechanically ventilated for 0.36 ± 0.20 (adjusted mean ± SE) log days, which was shorter (P = .033) than the 1.00 ± 0.22 logdays for subjects treated with epoprostenol. This resulted in an estimated median number of mechanically ventilated days for subjects treated with epoprostenol that was approximately 1.9 times longer than the estimated median number of ventilated days for subjects treated with iloprost (95% CI 1.05-3.4, P = .033). There were no differences in safety end points or length of hospital stay. CONCLUSIONS: Use of inhaled iloprost was associated with shorter duration of mechanical ventilation compared to inhaled epoprostenol, without safety concerns.

Electromagnetic Interference with Protocolized Electrosurgery Dispersive Electrode Positioning in Patients with Implantable Cardioverter Defibrillators.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: Electromagnetic interference from monopolar electrosurgery may disrupt implantable cardioverter defibrillators.Current management recommendations by the American Society of Anesthesiologists and Heart Rhythm Society are based on expert clinical opinion since there is a paucity of data regarding the risk of electromagnetic interference to implantable cardioverter defibrillators during surgery. WHAT THIS ARTICLE TELLS US THAT IS NEW: With protocolized electrosurgery dispersive electrode positioning in patients with implantable cardioverter defibrillators, the risk of clinically meaningful electromagnetic interference was 7% in above-the-umbilicus noncardiac surgery and 0% in below-the-umbilicus surgery. In cardiac surgery, clinically meaningful electromagnetic interference with use of an underbody dispersive electrode was 29%.Despite protocolized dispersive electrode positioning, the risk of electromagnetic interference in above-the-umbilicus surgery is high, supporting recommendations to suspend antitachycardia therapy when monopolar electrosurgery is used above the umbilicus.With protocolized dispersive electrode positioning, the risk of electromagnetic interference in below-the-umbilicus surgery is negligible, implying that suspending antitachycardia therapy might be unnecessary in these cases.With an underbody dispersive electrode, the risk of electromagnetic interference in cardiac surgery is high. BACKGROUND: The goal of this study was to determine the occurrence of intraoperative electromagnetic interference from monopolar electrosurgery in patients with an implantable cardioverter defibrillator undergoing surgery. A protocolized approach was used to position the dispersive electrode. METHODS: This was a prospective cohort study including 144 patients with implantable cardioverter defibrillators undergoing surgery between May 2012 and September 2016 at an academic medical center. The primary objectives were to determine the occurrences of electromagnetic interference and clinically meaningful electromagnetic interference (interference that would have resulted in delivery of inappropriate antitachycardia therapy had the antitachycardia therapy not been programmed off) in noncardiac surgeries above the umbilicus, noncardiac surgeries at or below the umbilicus, and cardiac surgeries with the use of an underbody dispersive electrode. RESULTS: The risks of electromagnetic interference and clinically meaningful electromagnetic interference were 14 of 70 (20%) and 5 of 70 (7%) in above-the-umbilicus surgery, 1 of 40 (2.5%) and 0 of 40 (0%) in below-the-umbilicus surgery, and 23 of 34 (68%) and 10 of 34 (29%) in cardiac surgery. Had conservative programming strategies intended to reduce the risk of inappropriate antitachycardia therapy been employed, the occurrence of clinically meaningful electromagnetic interference would have been 2 of 70 (2.9%) in above-the-umbilicus surgery and 3 of 34 (8.8%) in cardiac surgery. CONCLUSIONS: Despite protocolized dispersive electrode positioning, the risks of electromagnetic interference and clinically meaningful electromagnetic interference with surgery above the umbilicus were high, supporting published recommendations to suspend antitachycardia therapy whenever monopolar electrosurgery is used above the umbilicus. For surgery below the umbilicus, these risks were negligible, implying that suspending antitachycardia therapy is likely unnecessary in these patients. For cardiac surgery, the risks of electromagnetic interference and clinically meaningful electromagnetic interference with an underbody dispersive electrode were high. Conservative programming strategies would not have eliminated the risk of clinically meaningful electromagnetic interference in either noncardiac surgery above the umbilicus or cardiac surgery.

Cohort Study of Albumin versus Lactated Ringer's for Postoperative Cardiac Surgery Fluid Resuscitation in the Intensive Care Unit.

PURPOSE: A new postcardiac surgery fluid resuscitation strategy was implemented in our cardiovascular intensive care unit (CVICU) to implement evidence-based practice. We transitioned from a primarily albumin fluid-based strategy to a lactated Ringer's fluid-based strategy. We sought to determine whether a new postoperative fluid resuscitation strategy significantly altered the fluid composition for postcardiac surgery patients and what effect that would have on fluid resuscitation costs. Secondary outcomes included various clinical parameters. METHODS: This was a retrospective, before-and-after cohort study of postcardiac surgery patients in an academic quaternary care intensive care unit (ICU) during two different 3-month time intervals. A total of 192 patients were studied: 108 pre-intervention and 84 post intervention. The intervention consisted of surveying stakeholders regarding potential concerns of reducing albumin use, an educational intervention addressing those concerns, and removing albumin from the routine postcardiac surgery ICU admission order set. RESULTS: In the post intervention time period, albumin use decreased significantly compared to pre-invention (p<0.01), and lactated Ringer's volume increased significantly (p<0.01). However, total volume administered for resuscitation was not significantly different pre- and post intervention (1129 ml vs. 1369 ml, p=0.136). There were a net-cost savings between the pre-intervention and post intervention period (3 mo) of $30,549.20, with the albumin reduction accounting for most of those savings. Secondary outcomes were not significantly different between groups. CONCLUSIONS: An albumin fluid reduction strategy was successful in reducing the amount of albumin fluid used for postcardiac surgery patients and resulted in substantial cost savings.