Effect of Cricoid Pressure Compared With a Sham Procedure in the Rapid Sequence Induction of Anesthesia: The IRIS Randomized Clinical Trial.

Importance: The use of cricoid pressure (Sellick maneuver) during rapid sequence induction (RSI) of anesthesia remains controversial in the absence of a large randomized trial. Objective: To test the hypothesis that the incidence of pulmonary aspiration is not increased when cricoid pressure is not performed. Design, Setting, and Participants: Randomized, double-blind, noninferiority trial conducted in 10 academic centers. Patients undergoing anesthesia with RSI were enrolled from February 2014 until February 2017 and followed up for 28 days or until hospital discharge (last follow-up, February 8, 2017). Interventions: Patients were assigned to a cricoid pressure (Sellick group) or a sham procedure group. Main Outcomes and Measures: Primary end point was the incidence of pulmonary aspiration (at the glottis level during laryngoscopy or by tracheal aspiration after intubation). It was hypothesized that the sham procedure would not be inferior to the cricoid pressure. The secondary end points were related to pulmonary aspiration, difficult tracheal intubation, and traumatic complications owing to the tracheal intubation or cricoid pressure. Results: Of 3472 patients randomized, mean (SD) age was 51 (19) years and 1777 (51%) were men. The primary end point, pulmonary aspiration, occurred in 10 patients (0.6%) in the Sellick group and in 9 patients (0.5%) in the sham group. The upper limit of the 1-sided 95% CI of relative risk was 2.00, exceeding 1.50, failing to demonstrate noninferiority (P = .14). The risk difference was -0.06% (2-sided 95% CI, -0.57 to 0.42) in the intent-to-treat population and -0.06% (2-sided 95% CI, -0.56 to 0.43) in the per protocol population. Secondary end points were not significantly different among the 2 groups (pneumonia, length of stay, and mortality), although the comparison of the Cormack and Lehane grade (Grades 3 and 4, 10% vs 5%; P <.001) and the longer intubation time (Intubation time >30 seconds, 47% vs 40%; P <.001) suggest an increased difficulty of tracheal intubation in the Sellick group. Conclusions and Relevance: This large randomized clinical trial performed in patients undergoing anesthesia with RSI failed to demonstrate the noninferiority of the sham procedure in preventing pulmonary aspiration. Further studies are required in pregnant women and outside the operating room. Trial Registration: ClinicalTrials.gov Identifier: NCT02080754.

Fibrinogen on Admission in Trauma score: Early prediction of low plasma fibrinogen concentrations in trauma patients.

BACKGROUND: Early recognition of low fibrinogen concentrations in trauma patients is crucial for timely haemostatic treatment and laboratory testing is too slow to inform decision-making. OBJECTIVE: To develop a simple clinical tool to predict low fibrinogen concentrations in trauma patients on arrival. DESIGN: Retrospective cohort study. SETTING: Three designated level 1 trauma centres in the Paris Region, from January 2011 to December 2013. PATIENTS: Patients admitted in accordance with national triage guidelines for major trauma and plasma fibrinogen concentration testing on admission. INTERVENTION: Construction of a clinical score [Fibrinogen on Admission in Trauma (FibAT) score] in a derivation cohort to predict fibrinogen plasma concentration 1.5 g l or less after multiple regressions. One point was given for each predictive factor. The score was the sum of all. Validation was performed in a separate validation cohort. MAIN OUTCOME MEASURE: Predictive accuracy of FibAT score. RESULTS: In total, 2936 patients were included, 2124 in the derivation cohort and 812 in the validation cohort. In the derivation cohort, a multivariate logistic model identified the following predictive factors for plasma fibrinogen concentrations 1.5 g l or less: age less than 33 years, prehospital heart rate more than 100 beats per minute, prehospital SBP less than 100 mmHg, blood lactate concentration on admission more than 2.5 mmol l, free intraabdominal fluid on sonography, decrease in haemoglobin concentration from prehospital to admission of more than 2 g dl, capillary haemoglobin concentration on admission less than 12 g dl and temperature on admission less than 36°C. The FibAT score had an area under the receiver operating characteristic curve of 0.87 [95% confidence interval (0.86 to 0.91)] in the derivation cohort and of 0.82 (95% confidence interval (0.86 to 0.91)] in the validation cohort to predict a low plasma fibrinogen. CONCLUSION: The FibAT score accurately predicts plasma fibrinogen levels 1.5 g l or less on admission in trauma patients. This easy-to-use score could allow early, goal-directed therapy to trauma patients.

Incidence and risk factors of acute kidney injury associated with continuous intravenous high-dose vancomycin in critically ill patients: A retrospective cohort study.

For vancomycin therapy of severe infections, the Infectious Diseases Society of America recommends high vancomycin trough levels, whose potential for inducing nephrotoxicity is controversial. We evaluated the incidence and risk factors of acute kidney injury (AKI) in critically ill patients given continuous intravenous vancomycin with target serum vancomycin levels of 20 to 30 mg/L.We retrospectively studied 107 continuous intravenous vancomycin treatments of ≥48 hours' duration with at least 2 serum vancomycin levels ≥20 mg/L in critically ill patients. Nephrotoxicity was defined according to the Kidney Disease Improving Global Outcomes Clinical Practice Guideline for AKI (ie, serum creatinine elevation by ≥26.5 µmoL/L or to ≥1.5 times baseline). Risk factors for AKI were identified by univariate and multivariate analyses.AKI developed in 31 (29%) courses. Higher serum vancomycin levels were associated with AKI (P < 0.01). Factors independently associated with AKI were highest serum vancomycin ≥40 mg/L (odds ratio [OR], 3.75; 95% confidence interval [CI], 1.40-10.37; P < 0.01), higher cumulative number of organ failures (OR, 2.63 95%CI, 1.42-5.31; P < 0.01), and cirrhosis of the liver (OR, 5.58; 95%CI, 1.08-31.59; P = 0.04).In this study, 29% of critically ill patients had AKI develop during continuous intravenous vancomycin therapy targeting serum levels of 20 to 30 mg/L. Serum vancomycin level ≥40 mg/L was independently associated with AKI.

The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE).

BACKGROUND: During high-risk abdominal surgery the use of a multi-faceted lung protective ventilation strategy composed of low tidal volumes, positive end-expiratory pressure (PEEP) and recruitment manoeuvres, has been shown to improve clinical outcomes. It has been speculated, however, that mechanical ventilation using PEEP might increase intraoperative bleeding during liver resection. OBJECTIVE: To study the impact of mechanical ventilation with PEEP on bleeding during hepatectomy. DESIGN: Post-hoc analysis of a randomised controlled trial. SETTING: Seven French university teaching hospitals from January 2011 to August 2012. PARTICIPANTS: Patients scheduled for liver resection surgery. INTERVENTION: In the Intraoperative Protective Ventilation trial, patients scheduled for major abdominal surgery were randomly assigned to mechanical ventilation using low tidal volume, PEEP between 6 and 8  cmH2O and recruitment manoeuvres (lung protective ventilation strategy) or higher tidal volume, zero PEEP and no recruitment manoeuvres (non-protective ventilation strategy). MAIN OUTCOME AND MEASURE: The primary endpoint was intraoperative blood loss volume. RESULTS: A total of 79 (19.8%) patients underwent liver resections (41 in the lung protective and 38 in the non-protective group). The median (interquartile range) amount of intraoperative blood loss was 500 (200 to 800)  ml and 275 (125 to 800)  ml in the non-protective and lung protective ventilation groups, respectively (P = 0.47). Fourteen (35.0%) and eight (21.5%) patients were transfused in the non-protective and lung protective groups, respectively (P = 0.17), without a statistically significant difference in the median (interquartile range) number of red blood cells units transfused [2.5 (2 to 4) units and 3 (2 to 6) units in the two groups, respectively; P = 0.54]. CONCLUSION: During hepatic surgery, mechanical ventilation using PEEP within a multi-faceted lung protective strategy was not associated with increased bleeding compared with non-protective ventilation using zero PEEP. TRIAL REGISTRATION: The current study was not registered. The original Intraoperative Protective Ventilation study was registered on clinicaltrials.gov; number NCT01282996.

Assessment of the external validity of a predictive score for blood transfusion in liver surgery.

BACKGROUND: Perioperative bleeding is a predictor of morbidity following liver resection. The transfusion-related score (TRS), which is derived from five variables (cirrhosis, preoperative haemoglobin level, tumour size, vena cava exposure and associated extraliver surgical procedure), has been proposed to predict the likelihood of transfusion in liver resection. OBJECTIVE: The purpose of this observational study was to evaluate the external validity of the TRS. METHODS: In a retrospective, monocentre, observational cohort study of patients undergoing elective liver resection surgery, data for transfused and non-transfused patients were compared by univariate analysis. The TRS was calculated for each patient. The frequency of transfusion was calculated for each score level. The accuracy of the TRS was evaluated using the area under the receiver operator characteristic curve (AUC). RESULTS: A total of 205 patients submitted to liver resection were included. Of these, 48 (23.4%) patients received a blood transfusion. There was no significant difference between transfused and non-transfused patients in age, American Society of Anesthesiologists (ASA) score or cirrhosis. The AUC for the TRS was 0.68 (95% confidence interval 0.59-0.77). Among TRS items, only vena cava exposure and associated surgical procedures were significantly associated with risk for transfusion. CONCLUSIONS: In the present population, the TRS appeared to serve as a weak predictor of perioperative transfusion. This study confirms that the external validity of the transfusion predictive score should be subject to further investigation before it can be implemented in clinical use.

A trial of intraoperative low-tidal-volume ventilation in abdominal surgery.

BACKGROUND: Lung-protective ventilation with the use of low tidal volumes and positive end-expiratory pressure is considered best practice in the care of many critically ill patients. However, its role in anesthetized patients undergoing major surgery is not known. METHODS: In this multicenter, double-blind, parallel-group trial, we randomly assigned 400 adults at intermediate to high risk of pulmonary complications after major abdominal surgery to either nonprotective mechanical ventilation or a strategy of lung-protective ventilation. The primary outcome was a composite of major pulmonary and extrapulmonary complications occurring within the first 7 days after surgery. RESULTS: The two intervention groups had similar characteristics at baseline. In the intention-to-treat analysis, the primary outcome occurred in 21 of 200 patients (10.5%) assigned to lung-protective ventilation, as compared with 55 of 200 (27.5%) assigned to nonprotective ventilation (relative risk, 0.40; 95% confidence interval [CI], 0.24 to 0.68; P=0.001). Over the 7-day postoperative period, 10 patients (5.0%) assigned to lung-protective ventilation required noninvasive ventilation or intubation for acute respiratory failure, as compared with 34 (17.0%) assigned to nonprotective ventilation (relative risk, 0.29; 95% CI, 0.14 to 0.61; P=0.001). The length of the hospital stay was shorter among patients receiving lung-protective ventilation than among those receiving nonprotective ventilation (mean difference, -2.45 days; 95% CI, -4.17 to -0.72; P=0.006). CONCLUSIONS: As compared with a practice of nonprotective mechanical ventilation, the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization. (IMPROVE ClinicalTrials.gov number, NCT01282996.).

Effective dose of nefopam in 80% of patients (ED80): a study using the continual reassessment method.

AIMS: The effective dose in 50% of patients (ED(50)) is far from being relevant for clinical purposes. We used the continual reassessment method (CRM) to determine the effective dose of nefopam in 80% of the patients suffering from moderate pain in the postoperative period (ED(80)). METHODS: Patients with a pain intensity >3 on a 1-10 numerical pain score (NPS) received increasing or decreasing doses of nefopam (20, 30, 40, 60, 80 mg) postoperatively. The criterion of success was a NPS