Developing Treatment Guidelines During a Pandemic Health Crisis: Lessons Learned From COVID-19.

The development of the National Institutes of Health (NIH) COVID-19 Treatment Guidelines began in March 2020 in response to a request from the White House Coronavirus Task Force. Within 4 days of the request, the NIH COVID-19 Treatment Guidelines Panel was established and the first meeting took place (virtually-as did subsequent meetings). The Panel comprises 57 individuals representing 6 governmental agencies, 11 professional societies, and 33 medical centers, plus 2 community members, who have worked together to create and frequently update the guidelines on the basis of evidence from the most recent clinical studies available. The initial version of the guidelines was completed within 2 weeks and posted online on 21 April 2020. Initially, sparse evidence was available to guide COVID-19 treatment recommendations. However, treatment data rapidly accrued based on results from clinical studies that used various study designs and evaluated different therapeutic agents and approaches. Data have continued to evolve at a rapid pace, leading to 24 revisions and updates of the guidelines in the first year. This process has provided important lessons for responding to an unprecedented public health emergency: Providers and stakeholders are eager to access credible, current treatment guidelines; governmental agencies, professional societies, and health care leaders can work together effectively and expeditiously; panelists from various disciplines, including biostatistics, are important for quickly developing well-informed recommendations; well-powered randomized clinical trials continue to provide the most compelling evidence to guide treatment recommendations; treatment recommendations need to be developed in a confidential setting free from external pressures; development of a user-friendly, web-based format for communicating with health care providers requires substantial administrative support; and frequent updates are necessary as clinical evidence rapidly emerges.

Mass Casualties and Disaster Implications for the Critical Care Team.

Preparing for disasters both natural and anthropogenic requires assessment of risk through hazard vulnerability analysis and formulation of facility and critical care-specific disaster plans. Disaster surge conditions often require movement from conventional to contingency or crisis-level operations to meet the needs of the many under our care. Predisaster planning for modification of critical care space, staffing, and supplies is essential to successful execution of operations during a surge. Expansion of intensive care unit beds to nonconventional units such as perioperative areas, general care units, and even external temporary units may be necessary. Creative, tiered staffing models as well as just-in-time education of noncritical care clinicians and support staff are important to multiply capable personnel under surge conditions. Finally, anticipation of demand for key equipment and supplies is essential to maintain stockpiles, establish supply chains, and sustain operations under prolonged disaster scenarios.

The REBOA Dissipation Curve: Training Starts to Wane at 6 Months in the Absence of Clinical REBOA Cases.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a low-frequency, high-acuity intervention. We hypothesized that REBOA-specific knowledge and comfort deteriorate significantly within 6 months of a formal training course if REBOA is not performed in the interim. METHODS: A comprehensive REBOA course was developed including didactics and hands-on practical simulation training. Baseline knowledge and comfort were assessed with a precourse objective test and a subjective self-assessment. REBOA knowledge and comfort were then re-assessed immediately postcourse and again at 6 months and 1 year. Performance trends were measured using paired Student's t and Wilcoxon signed-rank tests. RESULTS: Thirteen participants were evaluated including trauma faculty (n = 10) and fellows (n = 3). Test scores improved significantly from precourse (72% ± 10% correct) to postcourse (88% ± 8%, p < 0.001). At 6 months, scores remained no different from postcourse (p = 0.126); at 1 year, scores decreased back to baseline (p = 0.024 from postcourse; 0.285 from precourse). Subjective comfort with femoral arterial line placement and REBOA improved with training (p = 0.044 and 0.003, respectively). Femoral arterial line comfort remained unchanged from postcourse at 6 months (p = 0.898) and 1 year (p = 0.158). However, subjective comfort with REBOA decreased relative to postcourse levels at 6 months (p = 0.009), driven primarily by participants with no clinical REBOA cases in the interim. CONCLUSIONS: A formal REBOA curriculum improves knowledge and comfort with critical aspects of this procedure. This knowledge persists at 6 months, though subjective comfort deteriorated among those without REBOA placement in the interim. REBOA refresher training should be considered at 6-month intervals in the absence of clinical REBOA cases. LEVEL OF EVIDENCE/STUDY TYPE: Level III, prognostic.

Intra-abdominal Hypertension and the Open Abdomen: Nursing Guidelines From the Abdominal Compartment Society.

Intra-abdominal hypertension has been identified as an independent risk factor for death in critically ill patients. Known risk factors for intra-abdominal hypertension indicate that intra-abdominal pressures should be measured and monitored. The Abdominal Compartment Society has identified medical and surgical interventions to relieve intra-abdominal hypertension or to manage the open abdomen if abdominal compartment syndrome occurs. The purpose of this article is to describe assessments and interventions for managing intra-abdominal hypertension and open abdomen that are within the scope of practice for direct-care nurses. These guidelines provide direction to critical care nurses caring for these patients.

Alternative Modes of Mechanical Ventilation.

Modern mechanical ventilators are more complex than those first developed in the 1950s. Newer ventilation modes can be difficult to understand and implement clinically, although they provide more treatment options than traditional modes. These newer modes, which can be considered alternative or nontraditional, generally are classified as either volume controlled or pressure controlled. Dual-control modes incorporate qualities of pressure-controlled and volume-controlled modes. Some ventilation modes provide variable ventilatory support depending on patient effort and may be classified as closed-loop ventilation modes. Alternative modes of ventilation are tools for lung protection, alveolar recruitment, and ventilator liberation. Understanding the function and application of these alternative modes prior to implementation is essential and is most beneficial for the patient.

Capnography Monitoring During Procedural Sedation and Analgesia.

Procedural sedation is used to alleviate pain and anxiety associated with diagnostic procedures in the acute care setting. Although commonly used, procedural sedation is not without risk. Key to reducing this risk is early identification of risk factors through presedation screening and monitoring during the procedure. Electrocardiogram, respiratory rate, blood pressure, and pulse oximetry commonly are monitored. These parameters do not reliably identify airway and ventilation compromise. Capnography measures exhaled carbon dioxide and provides early identification of airway obstruction and hypoventilation. Capnography is useful in patients receiving supplemental oxygen. In these patients, oxygen desaturation reported by pulse oximetry may lag during episodes of respiratory depression and apnea. Capnography indicates partial pressure of end-tidal carbon dioxide and provides information regarding airway integrity and patterns of ventilation compromise. Implementation of this technology may provide an additional layer of safety, reducing risk of respiratory compromise in patients receiving procedural sedation.

Preliminary Report on Stone Breakage and Lesion Size Produced by a New Extracorporeal Electrohydraulic (Sparker Array) Discharge Device.

OBJECTIVE: To determine if an innovative extracorporeal electrohydraulic shock wave (SW) device (sparker array [SPA]) can effectively fracture artificial stones in vitro and in vivo, and if SPA treatment produces a renal lesion in our pig model of lithotripsy injury. Results of these experiments will be used to help evaluate the suitability of this device as a clinical lithotripter. MATERIALS AND METHODS: Ultracal-30 artificial stones were placed in a holder at the focus of the SPA and treated with 600 SWs (21.6 kV, 60 shocks/min). Stone fragments were collected, dried, and weighed to determine stone breakage. In vivo stone breakage entailed implanting stones into pigs. These stones were treated with 600 or 1200 SWs and the fragments were collected for analysis. Lesion analysis consisted of treating the left kidney of pigs with 1200 or 2400 SWs and quantitating the hemorrhagic lesion. RESULTS: In vitro, 71% ± 2% of each artificial stone was fractured to <2 mm in size. In vivo stone breakage averaged 63%. Renal injury analysis revealed that only 1 of 7 kidneys showed evidence of hemorrhagic injury in the treated area. CONCLUSION: The SPA consistently comminuted artificial stones demonstrating its ability to fracture stones like other lithotripters. Also, the SPA caused little to no renal injury at the settings used in this study. These findings suggest further research is warranted to determine the potential of this device as a clinical lithotripter.

Evaluation of an experimental electrohydraulic discharge device for extracorporeal shock wave lithotripsy: Pressure field of sparker array.

In this paper, an extracorporeal shock wave source composed of small ellipsoidal sparker units is described. The sparker units were arranged in an array designed to produce a coherent shock wave of sufficient strength to fracture kidney stones. The objective of this paper was to measure the acoustical output of this array of 18 individual sparker units and compare this array to commercial lithotripters. Representative waveforms acquired with a fiber-optic probe hydrophone at the geometric focus of the sparker array indicated that the sparker array produces a shock wave (P+ ∼40-47 MPa, P- ∼2.5-5.0 MPa) similar to shock waves produced by a Dornier HM-3 or Dornier Compact S. The sparker array's pressure field map also appeared similar to the measurements from a HM-3 and Compact S. Compared to the HM-3, the electrohydraulic technology of the sparker array produced a more consistent SW pulse (shot-to-shot positive pressure value standard deviation of ±4.7 MPa vs ±3.3 MPa).

Staying connected: Service-specific orientation can be successfully achieved using a mobile application for onboarding care providers.

Communicating service-specific practice patterns, guidelines, and provider information to a new team of learners that rotate frequently can be challenging. Leveraging individual and healthcare electronic resources, a mobile device platform was implemented into a newly revised resident onboarding process. We hypothesized that offering an easy-to-use mobile application would improve communication across multiple disciplines as well as improve provider experiences when transitioning to a new rotation. A mobile platform was created and deployed to assist with enhancing communication within a trauma service and its resident onboarding process. The platform had resource materials such as: divisional policies, Clinical Practice Guidelines (CMGs), and onboarding manuals along with allowing for the posting of divisional events, a divisional directory that linked to direct dialing, text or email messaging, as well as on-call schedules. A mixed-methods study, including an anonymous survey, aimed at providing information on team member's impressions and usage of the mobile application was performed. Usage statistics over a 3-month period were analyzed on those providers who completed the survey. After rotation on the trauma service, trainees were asked to complete an anonymous, online survey addressing both the experience with, as well as the utility of, the mobile app. Thirty of the 37 (81%) residents and medical students completed the survey. Twenty-five (83%) trainees stated that this was their first experience rotating on the trauma service and 6 (20%) were from outside of the health system. According to those surveyed, the most useful function of the app were access to the directory (15, 50%), the divisional calendar (4, 13.3%), and the on-call schedules (3, 10%). Overall, the app was felt to be easy to use (27, 90%) and was accessed an average of 7 times per day (1-50, SD 9.67). Over half the survey respondents felt that the mobile app was helpful in completing their everyday tasks (16, 53.3%). Fifteen (50%) of the respondents stated that the app made the transition to the trauma service easier. Twenty-five (83.3%) stated it was valuable knowing about departmental events and announcements, and 17 (56.7%) felt more connected to the division. The evolution of mobile technology is rapidly becoming fundamental in medical education and training. We found that integrating a service-specific mobile application improved the learner's experience when transitioning to a new service and was a valuable onboarding instrument. Level of evidence IV.

Management of blunt pulmonary injury.

Thoracic injuries account for 25% of all civilian deaths. Blunt force injuries are a subset of thoracic injuries and include injuries of the tracheobronchial tree, pleural space, and lung parenchyma. Early identification of these injuries during initial assessment and resuscitation is essential to reduce associated morbidity and mortality rates. Management of airway injuries includes definitive airway control with identification and repair of tracheobronchial injuries. Management of pneumothorax and hemothorax includes pleural space drainage and control of ongoing hemorrhage, along with monitoring for complications such as empyema and chylothorax. Injuries of the lung parenchyma, such as pulmonary contusion, may require support of oxygenation and ventilation through both conventional and nonconventional mechanical ventilation strategies. General strategies to improve pulmonary function and gas exchange include balanced fluid resuscitation to targeted volume-based resuscitation end points, positioning therapy, and pain management.

Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry.

BACKGROUND: Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. METHODS AND RESULTS: We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. CONCLUSIONS: Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems.

Intra-abdominal hypertension: detecting and managing a lethal complication of critical illness.

Intra-abdominal hypertension occurs in 50% of all patients admitted to the intensive care unit and is associated with significant morbidity and mortality. Intra-abdominal hypertension is defined as a sustained, pathologic rise in intra-abdominal pressure to 12 mm Hg or more. Patients with intra-abdominal hypertension may progress to abdominal compartment syndrome. Early identification and treatment of this condition will improve patient outcome. Patients at risk for intra-abdominal hypertension include those with major traumatic injury, major surgery, sepsis, burns, pancreatitis, ileus, and massive fluid resuscitation. Predisposing factors include decreased abdominal wall compliance, increased intraluminal contents, increased peritoneal cavity contents, and capillary leak/fluid resuscitation.

Digital output volumetric pulmonary artery catheters eliminate interoperator interpretation variability and improve consistency of treatment decisions.

BACKGROUND: The pulmonary artery catheter (PAC) has been fraught with controversy over issues of safety and impact on outcomes variables for many years. Multiple attempts to quantify the utility of this diagnostic instrument have failed to resolve the matter. Previous investigations have focused on either quantifying inter-rater variability of waveform output interpretation from PACs or on clinical outcomes when PACs are used in care. We tested the hypothesis that the true link between a diagnostic tool and outcomes is treatment selection, and an instrument that minimizes or eliminates the need for data interpretation would also minimize the variability of treatment selections. STUDY DESIGN: We performed a prospective, single institutional, single blinded survey study. RESULTS: The inter-rater variability of waveform interpretation among all raters was notable (p < 0.01); for continuous end diastolic volume index interpretation, there was no notable inter-rater variability (p=1.0). Inter-rater variability of treatment selections based on waveform interpretation was notable for all raters (p < 0.01). Continuous end diastolic volume index data presentation of hemodynamic status did not result in notable inter-rater variability in treatment selections (p=0.10). Treatment choices based on continuous end diastolic volume index among raters with 5 or more years of experience are not different from clinical practice guideline-directed choices (p > 0.05), independent of patient ventilator status. CONCLUSIONS: Digital output volumetric PACs eliminate inter-rater variability of data interpretation, decrease inter-rater variability of data-driven treatment selections, and improve rater agreement with clinical practice guidelines when compared with traditional waveform output PACs.

Brugada syndrome and "Brugada sign": clinical spectrum with a guide for the clinician.

BACKGROUND: Patients with the manifest Brugada syndrome have an inordinate risk of sudden death and are candidates for implantation of a defibrillator. The Brugada type electrocardiogram (ECG) abnormality (the "Brugada sign"), however, is known to be associated with a wide range of conditions, many of which may not pose such a threat. Clinicians need guidance in choosing a rational approach for the evaluation and treatment of patients with a finding of the Brugada sign. METHODS: A systematic literature search was performed to identify publications on the Brugada syndrome and the Brugada-type ECG abnormality, with special emphasis on analyzing outcomes data. In addition, the ECG database of our institution was reviewed for tracings consistent with the Brugada sign, and, when possible, clinical correlations were made. RESULTS: Patients with the Brugada sign and a family history of sudden death or a personal history of syncope are at a high risk of sudden death and therefore should be strongly considered for implantation of a defibrillator. In patients who are hospitalized and critically ill, the Brugada sign is frequently the result of severe hyperkalemia, drug toxicity, or right ventricular injury. In most individuals with no symptoms and without a family history of sudden death, the Brugada sign is likely a normal variant. CONCLUSIONS: Most patients with the Brugada sign can be risk-stratified with simple clinical tools. Specific testing for the Brugada syndrome should be reserved for questionable cases and for the research setting. A provisional diagnostic-therapeutic algorithm is offered as a means of assisting the clinician in the evaluation and treatment of patients with the Brugada sign.