The Fragility Index of randomized controlled trials in pediatric anesthesiology.

PURPOSE: The P value is a widely used measure of statistical importance but has many drawbacks and limitations, one being that it does not reflect the robustness of the results of a clinical trial. The Fragility Index (FI) was developed as a measure of how many outcome events would need to change to nonevents to render a significant P value nonsignificant (P ≥ 0.05). The FI of trials from other medical specialties is typically < 5. We aimed to determine the FI of pediatric anesthesiology randomized controlled trials (RCT) and to test for association with various characteristics of the included trials. METHODS: We conducted a comprehensive systematic search of high-impact anesthesia, surgical, and medical journals from the last 25 years for trials comparing an intervention between two groups with a statistically significant P value (< 0.05) for a dichotomous outcome. We also compared FI values for variables that reflect the quality and importance of a trial. RESULTS: The median [interquartile range] FI was 3 [1-7] and correlated positively with the number of participants (rS = 0.41; P < 0.001) and events (rS = 0.42; P < 0.001), and negatively with the P value (rPB = -0.36; P < 0.001). Other measures of trial quality and impact or importance were not strongly associated with the FI. CONCLUSIONS: The FI of published trials in pediatric anesthesiology is similarly low as in other medical specialties. Larger trials with more events and P values ≤ 0.01 were associated with a higher FI.

RéSUMé: OBJECTIF: La valeur P est une mesure d'importance statistique largement utilisée, mais elle présente de nombreux inconvénients et limites, notamment parce qu'elle ne reflète pas la robustesse des résultats d'une étude clinique. L'indice de fragilité (IF) a été mis au point pour mesurer le nombre d'événements du critère d'évaluation qui devraient se transformer en non-événements pour obtenir une valeur P non significative (P ≥ 0,05). L'IF des études d'autres spécialités médicales est généralement < 5. Notre objectif était de déterminer l'IF des études randomisées contrôlées (ERC) en anesthésiologie pédiatrique et de tester l'association avec diverses caractéristiques des études incluses. MéTHODE: Nous avons réalisé une recherche systématique exhaustive dans les revues d'anesthésie, de chirurgie et médicales à fort impact des 25 dernières années pour trouver des études comparant une intervention entre deux groupes avec une valeur P significative d'un point de vue statistique (< 0,05) pour un résultat dichotomique. Nous avons également comparé les valeurs d'IF pour les variables qui reflètent la qualité et l'importance d'une étude. RéSULTATS: L'IF médian [écart interquartile] était de 3 [1 à 7] et était positivement corrélé avec le nombre de participant·es (rS = 0,41; P < 0,001) et d'événements (rS = 0,42; P < 0,001), et négativement avec la valeur P (rPB = -0,36; P < 0,001). D'autres mesures de la qualité et de l'impact ou de l'importance des études n'étaient pas fortement associées à l'IF. CONCLUSION: L'IF des études publiées en anesthésiologie pédiatrique est tout aussi faible que dans d'autres spécialités médicales. Des études plus importantes avec plus d'événements et des valeurs P ≤ 0,01 étaient associées à un IF plus élevé.

Intraoperative lung protective ventilation in peritonitis patients undergoing emergency laparotomy: A randomised controlled trial.

BACKGROUND AND AIMS: Lung protective ventilation (LPV) is recommended in acute respiratory distress syndrome. However, role of intraoperative LPV in elective laparotomy is controversial and it has not been evaluated in emergency laparotomy (EL). The aim of the study was to identify whether use of intraoperative LPV in EL in peritonitis patients reduces postoperative pulmonary complications (POPC). METHODS: After institutional ethics committee approval and informed written consent, 98 adult patients undergoing EL for peritonitis were randomised into two groups. Patients in group 1 received LPV (tidal volume 6-8 ml/kg, positive end expiratory pressure (PEEP) 6-8 cm H2O and recruitment manoeuvre every 30 min) and patients in group 2 received conventional ventilation (tidal volume 10-12 ml/kg, without PEEP/recruitment). Primary outcome was incidence of POPC on day 7. RESULTS: Data of 94 patients (n = 45 in group 1 & n = 49 in group 2) were available. Baseline demographic & laboratory parameters were comparable. Incidence of POPC was similar in both the groups [42.9% in group 1 vs. 53.3% in group 2; risk difference -10.4% (-30.6%, 9.6%); P = 0.31]. Mortality during hospital stay was 26.7% patients in group 1 and 26.5% patients in group 2 [risk difference (95% CI) 0.14%, (-17.7, 18.0); P = 0.98]. Length of hospital stay [median interquartile range (IQR) 13 (9-18) days in group 1 vs. 13 (8-21) days in group 2; P = 0.82] and length of intensive care unit stay [median (IQR) 7 (4-10) days vs. 6 (3-12) days; P = 0.88] were also similar in both groups. CONCLUSION: LPV during EL in peritonitis patients does not reduce the incidence of POPC compared to conventional ventilation.

Ultrasound is a reliable and faster tool for confirmation of endotracheal intubation compared to chest auscultation and capnography when performed by novice anaesthesia residents - A prospective controlled clinical trial.

BACKGROUND: Anesthesia trainee may initially take longer time to intubate and unintentionally place the endotracheal tube (ETT) in the esophagus. The present study determined if ultrasound is the fastest method of confirmation of correct placement of ETT compared to capnography, and chest auscultation in trainees. METHODS: First year anesthesia residents performed intubation in 120 patients recruited after ethical clearance and informed consent. Time to visualize flutter in trachea, double trachea sign, time to appearance of first and sixth capnography, and time to execute chest auscultation was noted. RESULTS: Ultrasonography was statistically fastest method to determine endotracheal intubation (36.50 ± 15.14 seconds) vs unilateral chest auscultation (50.29 ± 15.50 seconds) vs bilateral chest auscultation (51.90 ± 15.98 seconds) vs capnography first waveform (53.57 ± 15.97 seconds) vs capnography sixth waveform (61.67 ± 15.88 seconds). CONCLUSION: When teaching endotracheal intubation to novice anesthesia residents using conventional direct laryngoscopy, ultrasonography is the fastest method to confirm correct ETT placement compared to capnograph and chest auscultation. Mentor can guide trainee to direct ETT towards trachea and can promptly detect esophageal intubation by double trachea sign.