Quality of life of patients with hip fracture was better during the COVID-19 period than before, an ancillary study from the HiFIT multicenter study.

Background: The COVID-19 pandemic had a global impact on people life, notably because of lockdown periods. This could particularly affected patients suffering from hip fracture, who could have been more isolated during these periods. We aim at evaluating the impact of the COVID-19 period (including lockdown periods) on quality of life (QOL) in older adult patients 90 days after a surgery for a hip fracture. Subject and methods: Ancillary study of the prospective randomized controlled HiFIT study. We compared the QOL measured at 90 days after a hip fracture surgery using the EuroQOL-5 dimensions 3 levels (EQ-5D), the Perceived Quality of life (PQOL) and the Instrumental Activities of Daily Living (IADL) in patients included in the Hifit study before and during the COVID-19 pandemic. Results: The characteristics of the 161 patients included before and of the 213 included during the COVID period (including 122 (57%) during COVID with containment periods and 91 (43%) during COVID without containment periods) were similar (mean age 84 ± 10 years; 282 (75%) women). The majority (81%) of the patients alive at 90 days had returned to their previous place of residence in both periods. During the COVID period, EQ-5D showed better patient pain/discomfort and anxiety/depression levels. The PQOL happiness was not different, with around 81% of the patient being "happy" or "very happy" during the two periods and the IADL was also similar during the two periods. In the multivariate analysis odd ratios of having poorer outcomes were increased before COVID for pain/discomfort (OR 2.38, 95%CI [1.41-4.15], p = 0.001), anxiety (OR 1.89 [1.12-3.21], p = 0.017) and mobility (1.69 [1.02-2.86], p = 0.044). Conclusion: Patient's quality of life measured using different scales was not altered during the COVID period compared to before COVID, 90 days after a hip fracture. Surprisingly, the Pain/Discomfort and Anxiety dimensions of the EQ-5D questionnaires were even better during the COVID period.Clinical trial registration:https://clinicaltrials.gov/ (NCT02972294).

Validation of the postoperative Quality of Recovery-15 questionnaire after emergency surgery and association with quality of life at three months.

PURPOSE: The Quality of Recovery-15 (QoR-15) tool, validated for measuring postoperative recovery following scheduled surgeries, has not been psychometrically assessed in emergency contexts. Moreover, the QoR-15's associations with long-term outcomes remain underexplored. This study aimed to confirm the validity and reliability of the QoR-15 following emergency surgery and assess its association with three-month postoperative quality of life. METHODS: We conducted a prospective cohort study (August 2021-April 2022) on adult patients who underwent emergency surgery. The QoR-15 questionnaire was administered before surgery (H0) and at 24 hr (H24) and 48 hr (H48) after surgery. We examined the H24 score's associations with both the three-month quality of life, as assessed by the EQ-5D scale, and the number of days spent at home at 30 (DAH30) and 90 (DAH90) days. RESULTS: Of the 375 included patients, 352 (94%) completed the QoR-15 at H24 and 338 (90%) were followed up at three months. The population represented the following diverse surgical specialties: orthopedic (51%), gastrointestinal (27%), urologic (13%), and others (9%). The QoR-15 questionnaire confirmed all psychometric qualities (internal consistency, reproducibility, responsiveness, acceptability, construct, and convergent validities) in the emergency context. The average minimum clinical difference was 8.0 at H24. There was an association between QoR-15 at H24 and the three-month quality of life (r = 0.24; 95% confidence interval [CI], 0.14 to 0.34; P < 0.001), DAH30 (r = 0.33; 95% CI, 0.23 to 0.41; P < 0.001), and DAH90 (r = 0.31; 95% CI, 0.22 to 0.40; P < 0.001). CONCLUSION: The QoR-15 score is valid for measuring early postoperative recovery after emergency surgery. The H24 score significantly correlated with both the three-month quality of life and the number of days at home. STUDY REGISTRATION: ClinicalTrials.gov (NCT04845763); first submitted 11 April 2021.

RéSUMé: OBJECTIF: L'outil Quality of Recovery-15 (QoR-15), validé pour mesurer la récupération postopératoire après des chirurgies programmées, n'a pas fait l'objet d'une évaluation psychométrique dans des contextes d'urgence. De plus, l'association entre les réponses au QoR-15 et les devenirs à long terme demeure peu explorée. Cette étude visait à confirmer la validité et la fiabilité du QoR-15 après une chirurgie d'urgence et à évaluer son association avec la qualité de vie postopératoire à trois mois. MéTHODE: Nous avons mené une étude de cohorte prospective (août 2021-avril 2022) auprès de patient·es adultes ayant bénéficié d'une intervention chirurgicale d'urgence. Le questionnaire QoR-15 a été administré avant la chirurgie (H0), ainsi que 24 (H24) et 48 heures (H48) après la chirurgie. Nous avons examiné les associations du score à H24 avec la qualité de vie à trois mois, telle qu'évaluée par l'échelle EQ-5D, et le nombre de jours passés à la maison à 30 (DAH30) et 90 (DAH90) jours. RéSULTATS: Sur les 375 patient·es inclus·es, 352 (94 %) ont complété le QoR-15 à H24 et 338 (90 %) ont bénéficié d'un suivi à trois mois. La population représentait les diverses spécialités chirurgicales suivantes : orthopédique (51 %), gastro-intestinale (27 %), urologique (13 %) et autres (9 %). Le questionnaire QoR-15 a confirmé toutes les qualités psychométriques (cohérence interne, reproductibilité, réactivité, acceptabilité, construit et validités convergentes) dans le contexte de l'urgence. La différence clinique minimale moyenne était de 8,0 à H24. Il y avait une association entre le QoR-15 à H24 et la qualité de vie à trois mois (r = 0,24; intervalle de confiance à 95 % [IC], 0,14 à 0,34; P < 0,001), le DAH30 (r = 0,33; IC 95 %, 0,23 à 0,41; P < 0,001) et le DAH90 (r = 0,31; IC 95 %, 0,22 à 0,40; P < 0,001). CONCLUSION: Le score QoR-15 est valable pour mesurer la récupération postopératoire précoce après une intervention chirurgicale d'urgence. Le score à H24 était significativement corrélé à la fois à la qualité de vie à trois mois et au nombre de jours passés à la maison. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT04845763); soumis pour la première fois le 11 avril 2021.

Opioid-free Anesthesia Protocol on the Early Quality of Recovery after Major Surgery (SOFA Trial): A Randomized Clinical Trial.

BACKGROUND: Opioid-free anesthesia is increasingly being adopted to reduce opioid consumption, but its impact on early postoperative recovery after major surgery has not been evaluated in comparative trials. The hypothesis was that an opioid-free anesthesia protocol would enhance the early quality of recovery for patients undergoing scheduled major surgery under general anesthesia. METHODS: The SOFA study was a monocentric, randomized, controlled, assessor- and patient-blinded clinical trial conducted from July 10, 2021, to February 12, 2022. The eligible population included male and female patients undergoing scheduled major surgery, excluding bone procedures, that typically require opioids for postoperative pain management. Patients in the intervention group received a combination of at least two drugs among ketamine, lidocaine, clonidine, and magnesium sulfate, without opioids for anesthesia. The standard group received opioids. The primary outcome was early postoperative quality of recovery, assessed by Quality of Recovery-15 score at 24 h after surgery. Secondary outcomes were Quality of Recovery-15 at 48 and 72 h after surgery, incidence of chronic pain, and quality of life at 3 months. RESULTS: Of the 136 randomized patients, 135 were included in the primary analysis (mean age, 45.9 ± 15.7 yr; 116 females [87.2%]; 85 underwent major plastic surgery [63.9%]), with 67 patients in the opioid-free anesthesia group and 68 in the standard group. The mean Quality of Recovery-15 at 24 h was 114.9 ± 15.2 in the opioid-free anesthesia group versus 108.7 ± 18.1 in the standard group (difference, 6.2; 95% CI, 0.4 to 12.0; P = 0.026). Quality of Recovery-15 scores also differed significantly at 48 h (difference, 8.7; 95% CI, 2.9 to 14.5; P = 0.004) and at 72 h (difference, 7.3; 95% CI, 1.6 to 13.0; P = 0.013). There were no differences in other secondary outcomes. No major adverse events were noticed. CONCLUSIONS: The opioid-free anesthesia protocol improved quality of recovery after major elective surgery in a statistically but not clinically significant manner when compared to standard anesthesia.

Impact of early external ventricular drainage on functional outcome after traumatic brain injury: a bicentric retrospective cohort analysis.

PURPOSE: Several studies have confirmed that external ventricular drain decreases intracranial pressure (ICP) after traumatic brain injury (TBI). Considering its impact on ICP control and cerebral waste metabolites clearance, timing of external ventricular drain (EVD) insertion could improve CSF drainage efficiency. The aim of the study was to evaluate the impact of early EVD versus a later one on the 3-month outcome. METHODS: For this retrospective cohort study conducted in two regional trauma-center (Caen CHU Côte de Nacre and Beaujon Hospital) between May 2011 and March 2019, all patients with intracranial hypertension following TBI and treated with EVD were included. We defined the early EVD by drainage within the 24 h of the hospital admission and the late EVD insertion by drainage beyond 24 h. A poor outcome was defined as a Glasgow Outcome Scale of one or two at 3 months. RESULTS: Among the cohort of 671 patients, we analyzed 127 patients. Sixty-one (48.0%) patients had an early insertion of EVD. In the early EVD group, the mean time to insertion was 10 h versus 55 h in the late EVD group. Among the analyzed patients, 69 (54.3%) had a poor outcome including 39 (63.9%) in the early group and 30 (45.5%) in the later one. After adjustment on prognostic factors, early EVD insertion was not associated with a decrease in a poor outcome at 3-months (OR = 1.80 [0.73-4.53]). CONCLUSION: Early insertion of EVD (<24 h) for intracranial hypertension after TBI was not associated with improved outcome at 3 months.

Translation and validation of the French version of the ObsQoR-10 questionnaire for the evaluation of recovery after delivery: the ObsQoR-10-French.

Background: The Obstetric Quality of Recovery-10 (ObsQoR-10) is a validated tool for assessing the quality of postpartum recovery. This study aimed to validate the French version of the ObsQoR-10 scale (ObsQoR-10-French). Methods: After translating the ObsQoR-10 into French, we conducted a psychometric validation involving internal consistency, convergent validity, construct validity, reliability, responsiveness, scaling properties, acceptability, and feasibility. French women who underwent either a vaginal delivery (spontaneous or induced labour), or an emergency or elective Caesarean section (C-section) were prospectively included. They completed the ObsQoR-10-French before delivery and at 24 h (H24) and 48 h (H48) after delivery. Results: Of the 500 women included, 431 (86%) completed the questionnaire at all three timepoints. A total of 352 women (82%) underwent vaginal delivery (with 228 [53%] experiencing spontaneous labour and 124 [29%] had labour induced), whereas 53 (12%) women underwent an emergency C-section and 26 (6%) an elective C-section. The ObsQoR-10-French demonstrated excellent internal consistency with a Cronbach's coefficient of 0.81, 95% confidence interval 0.78-0.84 at H24. The tool was correlated with an 11-item global health score (P<0.001). Of the list of hypotheses for evaluating the construct validity, 81% were confirmed (negative associations between ObsQoR-10-French and length of labour, hospital stay, the need for a C-section, and the emergency level of the C-section). The Cohen effect size at H24 was 0.58. The intra-class coefficient was 0.90, 95% confidence interval 0.86-0.93 at H24. Conclusion: The ObsQoR-10-French is a valid and reliable psychometric questionnaire, capable of assessing the quality of postpartum recovery in French-speaking populations. Clinical trial registration: NCT04489602.

Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial.

BACKGROUND: Pain is frequent after cardiac surgery and source of multiple complications that can impair postoperative recovery. Regional anesthesia seems to be an interesting technique to reduce the pain in this context, but its effectiveness in improving recovery has been poorly studied so far. The objective of this study is to compare the effectiveness of two of the most studied chest wall blocks in cardiac surgery, i.e., the superficial and the deep parasternal intercostal plane blocks (SPIP and DPIP respectively), in addition to standard care, versus the standard care without regional anesthesia, on the quality of postoperative recovery (QoR) after cardiac surgery with sternotomy. METHODS: This is a single-center, single-blind, controlled, randomized trial with a 1:1:1 ratio. Patients (n = 254) undergoing cardiac surgery with sternotomy will be randomized into three groups: a control group with standard care and no regional anesthesia, a SPIP group with standard care and a SPIP, and a DPIP with standard care and a DPIP. All groups will receive the usual analgesic protocol. The primary endpoint is the value of the QoR evaluated by the QoR-15 at 24 h after the surgery. DISCUSSION: This study will be the first powered trial to compare the SPIP and the DPIP on global postoperative recovery after cardiac surgery with sternotomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05345639. Registered on April 26, 2022.

Epidemiology of surgery associated acute kidney injury (EPIS-AKI): a prospective international observational multi-center clinical study.

PURPOSE: The incidence, patient features, risk factors and outcomes of surgery-associated postoperative acute kidney injury (PO-AKI) across different countries and health care systems is unclear. METHODS: We conducted an international prospective, observational, multi-center study in 30 countries in patients undergoing major surgery (> 2-h duration and postoperative intensive care unit (ICU) or high dependency unit admission). The primary endpoint was the occurrence of PO-AKI within 72 h of surgery defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Secondary endpoints included PO-AKI severity and duration, use of renal replacement therapy (RRT), mortality, and ICU and hospital length of stay. RESULTS: We studied 10,568 patients and 1945 (18.4%) developed PO-AKI (1236 (63.5%) KDIGO stage 1500 (25.7%) KDIGO stage 2209 (10.7%) KDIGO stage 3). In 33.8% PO-AKI was persistent, and 170/1945 (8.7%) of patients with PO-AKI received RRT in the ICU. Patients with PO-AKI had greater ICU (6.3% vs. 0.7%) and hospital (8.6% vs. 1.4%) mortality, and longer ICU (median 2 (Q1-Q3, 1-3) days vs. 3 (Q1-Q3, 1-6) days) and hospital length of stay (median 14 (Q1-Q3, 9-24) days vs. 10 (Q1-Q3, 7-17) days). Risk factors for PO-AKI included older age, comorbidities (hypertension, diabetes, chronic kidney disease), type, duration and urgency of surgery as well as intraoperative vasopressors, and aminoglycosides administration. CONCLUSION: In a comprehensive multinational study, approximately one in five patients develop PO-AKI after major surgery. Increasing severity of PO-AKI is associated with a progressive increase in adverse outcomes. Our findings indicate that PO-AKI represents a significant burden for health care worldwide.

Ferric derisomaltose and tranexamic acid, combined or alone, for reducing blood transfusion in patients with hip fracture (the HiFIT trial): a multicentre, 2 × 2 factorial, randomised, double-blind, controlled trial.

BACKGROUND: Anaemia and blood transfusion are associated with poor outcomes after hip fracture. We evaluated the efficacy of intravenous iron and tranexamic acid in reducing blood transfusions after hip fracture surgery. METHODS: In this double-blind, randomised, 2 × 2 factorial trial, we recruited adults hospitalised for hip fractures in 12 medical centres in France who had preoperative haemoglobin concentrations between 9·5 and 13·0 g/dL. We randomly allocated participants (1:1:1:1), via a secure web-based service, to ferric derisomaltose (20 mg/kg intravenously) and tranexamic acid (1 g bolus followed by 1 g over 8 h intravenously at inclusion and 3 g topically during surgery), iron plus placebo (normal saline), tranexamic acid plus placebo, or double placebo. Unmasked nurses administered study drugs; participants and other clinical and research staff remained masked to treatment allocation. The primary outcome was the percentage of patients transfused during hospitalisation (or by day 30). The primary analysis included all randomised patients. This study is registered on ClinicalTrials.gov (NCT02972294) and is closed to new participants. FINDINGS: Of 413 patients (51-104 years old, median [IQR] 86 [78-91], 312 [76%] women, 101 [24%] men), 104 received iron plus tranexamic acid, 103 iron plus placebo, 103 tranexamic acid plus placebo, and 103 double placebo between March 31, 2017 and June 18, 2021 (study stopped early for efficacy after the planned interim analysis done on the first 390 patients included on May 25, 2021). Data for the primary outcome were available for all participants. Among patients on double placebo, 31 (30%) were transfused versus 16 (15%) on both drugs (relative risk 0·51 [98·3% CI 0·27-0·97]; p=0·012). 27 (26%) participants on iron (0·81 [0·50-1·29]; p=0·28) and 28 (27%) on tranexamic acid (0·85 [0·54-1·33]; p=0·39) were transfused. 487 adverse events were reported with similar event rates among the groups; among prespecified safety endpoints, severe postoperative anaemia (haemoglobin <8 g/dL) was more frequent in the double placebo group. Main common adverse event were sepsis, pneumonia, and urinary infection, with similar rates among all groups. INTERPRETATION: In patients hospitalised for hip fracture surgery with a haemoglobin concentration 9·5-13·0 g/dL, preoperative infusion of ferric derisomaltose plus tranexamic acid reduced the risk of blood transfusion by 50%. Our results suggest that combining treatments from two different pillars improves patient blood-management programmes. Either treatment alone did not reduce transfusion rates, but we might not have had the power to detect it. FUNDING: French Ministry of Health, HiFIT trial.

Postoperative transfusion hemoglobin threshold and functional recovery after high-risk oncologic surgery: A randomized controlled pilot study.

BACKGROUND: Robust evidence to inform best transfusion management after major oncologic surgery, where postoperative recovery might impact treatment regimens for cancer, is lacking. We conducted a study to validate the feasibility of a larger trial comparing liberal versus restrictive red blood cells (RBC) transfusion strategies after major oncologic surgery. STUDY DESIGN AND METHODS: This was a two-center, randomized, controlled, study of patients admitted to the intensive care unit after major oncologic surgery. Patients whose hemoglobin level dropped below 9.5 g/dL, were randomly assigned to immediately receive a 1-unit RBC transfusion (liberal) or delayed until the hemoglobin level dropped below 7.5 g/dL (restrictive). The primary outcome was the median hemoglobin level between randomization to day 30 post-surgery. Disability-free survival was evaluated by the WHODAS 2.0 questionnaire. RESULTS: 30 patients were randomized (15 patients/group) in 15 months with a mean recruitment rate of 1.8 patients per month. The median hemoglobin level was significantly higher in the liberal group than in the restrictive group: 10.1 g/dL (IQR 9.6-10.5) versus 8.8 g/dL (IQR 8.3-9.4), p < .001, and RBC transfusion rates were 100% versus 66.7%, p = .04. The disability-free survival was similar between groups: 26.7% versus 20%, p = 1. DISCUSSION: Our results support the feasibility of a phase 3 randomized controlled trial comparing the impact of liberal versus restrictive transfusion strategies on the functional recovery of critically ill patients following major oncologic surgery.

Spin and fragility in randomised controlled trials in the anaesthesia literature: a systematic review.

BACKGROUND: Given variable frequency of misleading reports and the potential for spin (a way of describing results that can mislead readers) to influence interpretation of randomised controlled trials (RCTs), we have undertaken a spin reassessment. We evaluated the quality of recent literature in anaesthesia journals by assessing the presence of spin and calculating the fragility index. METHODS: This systematic review of randomised trials was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We searched via PubMed® from January 1, 2019 to January 1, 2021 to identify all RCTs published in one of the 20 anaesthesia journals with the highest journal impact factors during this time. Four pairs of reviewers assessed articles independently for eligibility using a piloted electronic data extraction form. They assessed the presence of spin in statistically negative RCTs and calculated the fragility index for statistically positive RCTs. RESULTS: Of the 802 screened records, 162 (20%) articles were analysed for spin, and 65 (8%) trials were analysed for fragility index. For the statistically negative studies, 66 articles (40%) presented spin; 89% of these occurrences of spin were described in the conclusion of the abstract. The primary type of spin was the highlight of secondary outcomes (67%). For statistically positive trials, the median fragility index was 4 [1-8]. CONCLUSIONS: This systematic review showed that 40% of statistically negative trials in high-impact anaesthesia journals could mislead readers. For statistically positive RCTs, the results relied on few subjects, with a median fragility index of 4 [1-8]. Efforts must be continued to reduce spin and fragility in the medical literature.

Risk Factors and Consequences of Late-Onset Hyperlactatemia After Cardiac Surgery With Cardiopulmonary Bypass: A Single-Center Retrospective Study.

OBJECTIVE: Mechanisms and consequences of late-onset hyperlactatemia after cardiac surgery remain unclear. The aim of this study was to identify risk factors and outcomes of late hyperlactatemia, defined as a lactate value ≥3 mmol/L developing in the intensive care unit (ICU) after not being elevated on admission after cardiac surgery with cardiopulmonary bypass. DESIGN: A retrospective analysis of prospectively collected data. SETTING: A single-center University Hospital. PARTICIPANTS: Patients who underwent elective cardiac surgery with cardiopulmonary bypass in 2019 and who had normal lactatemia at ICU admission. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Patients were divided in 2 groups according to their lactatemia on postoperative day 1 (14.0 ± 3.0 hours after ICU admission): normal lactatemia (control group) and late hyperlactatemia (HL group). Risk factors for late hyperlactatemia were identified using a multivariate analysis, and postoperative outcomes were compared using a composite criterion of severe outcomes. Of the 432 included patients, 37 (8.5%) presented with late hyperlactatemia. Risk factors independently associated with hyperlactatemia were afternoon surgery (odds ratio [OR] 4.24, 95% CI 2.00-9.35), a bleeding >300 mL within the 6 hours after surgery (H6) (OR 3.77, 95% CI 1.71-8.30), and H6 fluid loading >250 mL (OR 2.64, 95% CI 1.22-5.55). Patients with hyperlactatemia presented more frequently with major postoperative complications, including acute kidney injury, and received more frequent red-cell transfusion. CONCLUSION: The strongest risk factors associated with late-onset hyperlactatemia in the authors' population were afternoon surgery and H6 bleeding >300 mL. Poor postoperative outcomes were more frequent in patients with late hyperlactatemia, even in the absence of early hyperlactatemia or severe obvious condition.

Early use of barbiturates is associated with increased mortality in traumatic brain injury patients from a propensity score-based analysis of a prospective cohort.

Barbiturates are proposed as a second/third line treatment for intracranial hypertension in traumatic brain injury (TBI) patients, but the literature remains uncertain regarding their benefit/risk balance. We aimed to evaluate the impact of barbiturates therapy in TBI patients with early intracranial hypertension on the intensive care unit (ICU) survival, the occurrence of ventilator-associated pneumonia (VAP), and the patient's functional status at three months. We used the French AtlanREA prospective cohort of trauma patients. Using a propensity score-based methodology (inverse probability of treatment weighting), we compared patients having received barbiturates within the first 24 hours of admission (barbiturates group) and those who did not (control group). We used cause-specific Cox models for ICU survival and risk of VAP, and logistic regression for the 3-month Glasgow Outcome Scale (GOS) evaluation. Among the 1396 patients with severe trauma, 383 had intracranial hypertension on admission and were analyzed. Among them, 96 (25.1%) received barbiturates. The early use of barbiturates was significantly associated with increased ICU mortality (HR = 1.85, 95%CI 1.03-3.33). However, barbiturates treatment was not significantly associated with VAP (HR = 1.02, 95%CI 0.75-1.41) or 3-month GOS (OR = 1.67, 95%CI 0.84-3.33). Regarding the absence of relevant clinical trials, our results suggest that each early prescription of barbiturates requires a careful assessment of the benefit/risk ratio.

Impact on Postoperative Pain and Recovery of a Regional Analgesia Strategy Based on the Surgical Approach for Lung Resection: A Prospective Observational Study.

Various regional anesthesia (RA) techniques were shown to reduce pain after lung surgery, but controversies remain regarding the best technique to use to improve recovery. In this observational prospective study, the aim was to assess the efficacy of an RA strategy depending on the surgical approach. Patients who underwent lung surgery were included if an RA was planned following our unit procedure (erector spinae plane block (ESP) for video-assisted thoracic surgery (VATS) and thoracic epidural analgesia (TEA) or intrathecal analgesia (IA) for thoracotomy). Patients were compared according to the RA used. In total, 116 patients were included, 70 (60%), 32 (28%), 14 (12%) in the ESP, TEA and IA groups, respectively. Between Day 1 and Day 3, median NRS values were ≤4 at rest, and <50% patients experienced moderate-to-severe pain in each group. There were no significant differences in opioid consumption and in pain at rest or during chest physiotherapy on Days 1 and 2 between groups. However, patients who received an IA had lower NRS than other groups on Day 0 and 3 and a shorter length of hospital stay in comparison with those who received a TEA. Thus, in our institution, a strategy combining ESP for VATS and TEA, or IA for thoracotomy, allowed for effective analgesia after a lung resection. Interestingly, IA appeared to be more effective than TEA in reducing the length of hospital stay and pain on Day 0 and 3.

Causal inference in case of near-violation of positivity: comparison of methods.

In causal studies, the near-violation of the positivity may occur by chance, because of sample-to-sample fluctuation despite the theoretical veracity of the positivity assumption in the population. It may mostly happen when the exposure prevalence is low or when the sample size is small. We aimed to compare the robustness of g-computation (GC), inverse probability weighting (IPW), truncated IPW, targeted maximum likelihood estimation (TMLE), and truncated TMLE in this situation, using simulations and one real application. We also tested different extrapolation situations for the sub-group with a positivity violation. The results illustrated that the near-violation of the positivity impacted all methods. We demonstrated the robustness of GC and TMLE-based methods. Truncation helped in limiting the bias in near-violation situations, but at the cost of bias in normal conditions. The application illustrated the variability of the results between the methods and the importance of choosing the most appropriate one. In conclusion, compared to propensity score-based methods, methods based on outcome regression should be preferred when suspecting near-violation of the positivity assumption.

Spontaneous Breathing for Panendoscopy? Retrospective Cohort and Results of a French Practice Survey.

OBJECTIVE: Avoiding tracheal intubation by using general anesthesia with spontaneous breathing (GASB) is attractive for upper airway panendoscopy. The aim of this study was to estimate the incidence of adverse events during panendoscopy under GASB and to assess the practices of French anesthesiologists. STUDY DESIGN: Two-phase study: monocentric retrospective study and national survey. SETTING: University hospital center. METHODS: Patients who underwent a panendoscopy under GASB at the University Hospital of Angers between January 1 and December 31, 2014, were reviewed. Failure of GASB was defined as an episode of hypoxemia (SpO2 ≤88%) or the need for face mask ventilation with or without tracheal intubation. Then, we sent an electronic survey to all members of the French Society of Anaesthesia and Intensive Care. RESULTS: Among the 95 included patients, 22 (23%) experienced a failure of GASB: 3 tolerated hypoxemia, 15 had face mask ventilation episodes, and 4 were intubated. Three factors were associated with failure: obesity (odds ratio, 11.94; 95% CI, 3.20-44.64), history of difficult intubation defined as a Cormack score ≥3 (odds ratio, 6.20; 95% CI, 1.51-25.41), and laryngeal tumor (odds ratio, 2.81; 95% CI, 1.04-7.56). Among the 3930 members of the French Society of Anaesthesia and Intensive Care in 2018, 662 (16.8%) responded to the survey. The 2 preferred techniques to perform panendoscopy were intubation (62%) and intravenous sedation with spontaneous breathing (37%). CONCLUSION: Although general anesthesia with orotracheal intubation remains the preferred technique for panendoscopy in France, GASB is an attractive alternative with a low failure rate. Risk factors for failure are obesity, history of difficult intubation, and laryngeal tumor.

Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery.

STUDY OBJECTIVE: The QoR-15 scale is a validated tool to assess the quality of postoperative recovery (QoR). Our objective was to assess the association between the early QoR-15 values and the occurrence of one-month postoperative complications. DESIGN: We used the data from a prospective single-centre cohort study conducted in the Angers University Hospital from July 2019 to February 2020 that validated the French version of the QoR-15 (FQoR-15). SETTING: Preoperative room, ward, and home. PATIENTS: 363 French-speaking adult patients, undergoing elective surgery, were enrolled (217 (59,8%) men, median age 60 (range 44 to 71) years old), including 139 (38.3%) ambulatory surgeries. INTERVENTION: Patients completed the QoR-15 scale the day before, at 24 and 48 h after surgery. MEASUREMENTS: Postoperative complications were recorded according to the PostOperative Morbidity Survey (POMS) classification till 30 days after surgery. The QoR was classified as excellent (QoR-15 > 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) or poor (QoR-15 < 90). Days alive and out of hospital up to 30 days after surgery was also recorded. MAIN RESULTS: According to the POMS classification, 176 (48.5%) patients had at least one complication up to 30 days after surgery. Among the 69 (19.0%) patients with a poor recovery at H24, 58 (84.1%) had at least one complication up to 30 days after surgery compared to 10 (23.8%) among the 42 (11.6%) in the excellent recovery group (p < 0.0001). The QoR-15 score at H24 allowed suitable discrimination of the occurrence of at least one complication up to 30 days after surgery (AUC 0.732 (95% CI 0.680 to 0.784)). CONCLUSION: The early QoR-15 scale after surgery is moderately associated with the occurrence of postoperative complications up to 30 days after elective surgeries (i.e. it has predictive validity).

Cognitive Aid for Anesthetic Preparation in An Emergency Situation: A Simulation-Based Study.

When anesthesia checklists and preparations are performed urgently, omissions may occur and be deleterious to the patient. The aim of this study was to evaluate in simulation the interest of a cognitive aid to effectively prepare an anesthetic room for an emergency. In a prospective single-center simulation-based study, 32 anesthesia residents had to prepare an anesthetic room in an emergency scenario, without cognitive aid in the first phase. Three months later (phase 2), they were randomly assigned to receive a cognitive aid (aid group) or no additional aid (control) and were involved in the same scenario. The primary outcome was the validation rate of each essential item in the first 5 min in phase 2. Eight items were significantly more frequently completed in the first 5 min in the aid group in phase 2 (vs. phase 1), compared with two only in the control group. However, there were no significant differences in the overall number of completed items between the two groups, as both groups completed significantly more items in phase 2, either in the first 5 min (19 (14-23) vs. 13 (9-15) in phase 1 for all residents, p < 0.001) or without time limit. Preparation times were reduced in phase 2 in both groups. In conclusion, the use of a cognitive aid allowed anesthesia residents to complete some safety items of a simulated urgent anesthesia preparation more frequently. In addition, despite daily clinical experience, a single simulation session improved anesthesia preparation and reduced the preparation time with or without cognitive aid.

The effect of opioid-free anesthesia protocol on the early quality of recovery after major surgery (SOFA trial): study protocol for a prospective, monocentric, randomized, single-blinded trial.

BACKGROUND: Since the 2000s, opioid-free anesthesia (OFA) protocols have been spreading worldwide in anesthesia daily practice. These protocols avoid using opioid drugs during anesthesia to prevent short- and long-term opioid side effects while ensuring adequate analgesic control and optimizing postoperative recovery. Proofs of the effect of OFA protocol on optimizing postoperative recovery are still scarce. The study aims to compare the effects of an OFA protocol versus standard anesthesia protocol on the early quality of postoperative recovery (QoR) from major surgeries. METHODS: The SOFA trial is a prospective, randomized, parallel, single-blind, monocentric study. Patients (n = 140) scheduled for major plastic, visceral, urologic, gynecologic, or ear, nose, and throat (ENT) surgeries will be allocated to one of the two groups. The study group (OFA group) will receive a combination of clonidine, magnesium sulfate, ketamine, and lidocaine. The control group will receive a standard anesthesia protocol based on opioid use. Both groups will receive others standard practices for general anesthesia and perioperative care. The primary outcome measure is the QoR-15 value assessed at 24 h after surgery. Postoperative data such as pain intensity, the incidence of postoperative complication, and opioid consumption will be recorded. We will also collect adverse events that may be related to the anesthetic protocol. Three months after surgery, the incidence of chronic pain and the quality of life will be evaluated by phone interview. DISCUSSION: This will be the first study powered to evaluate the effect of OFA versus a standard anesthesia protocol using opioids on global postoperative recovery after a wide range of major surgeries. The SOFA trial will also provide findings concerning the OFA impact on chronic pain incidence and long-term patient quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT04797312. Registered on 15 March 2021.