Knowledge-based, computerized, patient clinical decision support system for perioperative pain, nausea and constipation management: a clinical feasibility study.

Opioid administration is particularly challenging in the perioperative period. Computerized-based Clinical Decision Support Systems (CDSS) are a promising innovation that might improve perioperative pain control. We report the development and feasibility validation of a knowledge-based CDSS aiming at optimizing the management of perioperative pain, postoperative nausea and vomiting (PONV), and laxative medications. This novel CDSS uses patient adaptive testing through a smartphone display, literature-based rules, and individual medical prescriptions to produce direct medical advice for the patient user. Our objective was to test the feasibility of the clinical use of our CDSS in the perioperative setting. This was a prospective single arm, single center, cohort study conducted in Strasbourg University Hospital. The primary outcome was the agreement between the recommendation provided by the experimental device and the recommendation provided by study personnel who interpreted the same care algorithm (control). Thirty-seven patients were included in the study of which 30 (81%) used the experimental device. Agreement between these two care recommendations (computer driven vs. clinician driven) was observed in 51 out 54 uses of the device (94.2% [95% CI 85.9-98.4%]). The agreement level had a probability of 86.6% to exceed the 90% clinically relevant agreement threshold. The knowledge-based, patient CDSS we developed was feasible at providing recommendations for the treatment of pain, PONV and constipation in a perioperative clinical setting.Trial registration number & date The study protocol was registered in ClinicalTrial.gov before enrollment began (NCT05707247 on January 26th, 2023).

Pictorial adaptation of the quality of recovery 15 scale and psychometric validation into a pediatric surgical population.

Patient reported outcomes measures (PROMS) are important endpoints to measure patient health status in the perioperative setting. However, there are no good tools to measure PROMS in the pediatric surgical population. Patients 7 to 17 years old undergoing surgery were included and followed up for 1 day after surgery (POD1). At POD1 the patients were asked to rate their overall postoperative recovery using a 100-mm visual analog scale (VAS). The primary outcome was the pediatric QoR-15 score on postoperative day 1 (POD1). 150 patients completed the study. The mean (SD) pediatric QoR-15F scores were 132.1 (14.1) and 111.0 (27.0), preoperatively and on POD1, respectively. Convergent validity confirmed with Pearson (r) correlation between the postoperative pediatric QoR-15F and the patient-rated global recovery assessment was 0.72 (95% confidence interval [0.63-0.79]; p < 10-16). Concerning reliability, internal consistency of the pediatric QoR-15 assessed by Cronbach's alpha was 0.90. The test-retest concordance correlation coefficient was 0.92; 95% CI [0.83-0.96]. Split-half alpha was 0.74. The pictorial pediatric version of the QoR-15F showed good validity, reliability, responsiveness, acceptability and feasibility. This PROMS should be considered for clinical care and research in the perioperative pediatric patient setting.Trial Registration: NCT04453410 on clinicaltrials.gov.

Early perioperative quality of recovery after hip and knee arthroplasty: a retrospective comparative cohort study.

PURPOSE: Increasing our knowledge about postoperative global Quality-Of-Recovery (QoR) after THA and TKA is important to improve perioperative medicine, in particular for preoperative patient information and benchmarking of postoperative patient status. METHODS: This study is a single centre, retrospective cohort study of prospectively collected data, conducted in Strasbourg University Hospital, Strasbourg, France. The main outcome was the modified French version of the QoR-15 (mQoR-15F) score monitored preoperatively, at postoperative day one, three, 14 and 28. We questioned the hypothesis: would THA and TKA recovery patterns differ and would postoperative health status eventually overreach the preoperative reference? RESULTS: The mQoR-15F was statistically higher in the THA group compared to the TKA group in POD 1 and 28 (112 ± 17 vs. 107 ± 17; p < 0.01 and 131 ± 12 vs. 127 ± 15; p = 0.02, respectively). The mean postoperative time delay to reach preoperative mQoR-15F was seven and 16 days for THA and TKA patients, respectively. CONCLUSION: Early postoperative health status after THA and TKA differs significantly; TKA being associated with a larger early decrease of global health status compared to THA. Both THA and TKA groups global health status overreached preoperative levels after one and two weeks postoperatively. These surgery-specific recovery profiles may favor improved patient information to steer advised operative decision and set specific recovery goals as part of enhanced recovery pathways.

Intraoperative hypotension when using hypotension prediction index software during major noncardiac surgery: a European multicentre prospective observational registry (EU HYPROTECT).

Background: Intraoperative hypotension is associated with organ injury. Current intraoperative arterial pressure management is mainly reactive. Predictive haemodynamic monitoring may help clinicians reduce intraoperative hypotension. The Acumen™ Hypotension Prediction Index software (HPI-software) (Edwards Lifesciences, Irvine, CA, USA) was developed to predict hypotension. We built up the European multicentre, prospective, observational EU HYPROTECT Registry to describe the incidence, duration, and severity of intraoperative hypotension when using HPI-software monitoring in patients having noncardiac surgery. Methods: We enrolled 749 patients having elective major noncardiac surgery in 12 medical centres in five European countries. Patients were monitored using the HPI-software. We quantified hypotension using the time-weighted average MAP <65 mm Hg (primary endpoint), the proportion of patients with at least one ≥1 min episode of a MAP <65 mm Hg, the number of ≥1 min episodes of a MAP <65 mm Hg, and duration patients spent below a MAP of 65 mm Hg. Results: We included 702 patients in the final analysis. The median time-weighted average MAP <65 mm Hg was 0.03 (0.00-0.20) mm Hg. In addition, 285 patients (41%) had no ≥1 min episode of a MAP <65 mm Hg; 417 patients (59%) had at least one. The median number of ≥1 min episodes of a MAP <65 mm Hg was 1 (0-3). Patients spent a median of 2 (0-9) min below a MAP of 65 mm Hg. Conclusions: The median time-weighted average MAP <65 mm Hg was very low in patients in this registry. This suggests that using HPI-software monitoring may help reduce the duration and severity of intraoperative hypotension in patients having noncardiac surgery.

Effect of surgical delay on 30-day mortality in patients receiving direct oral anticoagulants and admitted for hip fracture.

BACKGROUND: Early hip fracture surgery is recommended to decrease mortality, however the impact of a delay in surgery due to previous treatment with direct oral anticoagulants (DOA) is unknown. Our objective was to determine if early surgery, defined as surgery within 48 h of hospital admission is associated with decreased postoperative mortality. We tested the hypothesis that early surgery was beneficial with regard for mortality in patients treated with direct oral anticoagulants. METHODS: Retrospective cohort study in a French University Hospital including patient admitted for Hip fracture. The main exposure was wait time for surgery defined as the total time, in hours, between hospital admission and surgery. The main outcome was mortality within 30 days after hip fracture surgery. RESULTS: In 3429 patients, the overall 30-day mortality was 4.1% (95% CI 3.5%; 4.9%). In DOA + patients, the 30-day mortality rates in the early and delayed surgery groups were 1.2% and 5.9%, respectively, with estimated risk difference of -4.4 (with a 2% probability of this difference is > 0). In the DOA + group, early surgery tended to be associated with a higher percentage receiving red-blood cells (64.6% vs 54.8%, respectively, estimated risk difference of 9.9% with a 93% probability of this difference is > 0) and lower risk of pneumonia (1.2% vs 8.2%, respectively; estimated difference of -6.7% with 0.3% probability of superiority). CONCLUSION: Early hip fracture surgery was associated with improved survival in patients previously treated with DOAs.

Association of preoperative COVID-19 and postoperative respiratory morbidity during the Omicron epidemic wave: the DROMIS-22 multicentre prospective observational cohort study.

Background: Preoperative COVID-19 has been associated with excess postoperative morbi-mortality. Consequently, guidelines were developed that recommended the postponement of surgery for at least 7 weeks after the infection. We hypothesised that vaccination against the SARS-CoV-2 and the large predominance of the Omicron variant attenuated the effect of a preoperative COVID-19 on the occurrence of postoperative respiratory morbidity. Methods: We conducted a prospective cohort study in 41 French centres between 15 March and 30 May 2022 (ClinicalTrials NCT05336110), aimed at comparing the postoperative respiratory morbidity between patients with and without preoperative COVID-19 within 8 weeks prior to surgery. The primary outcome was a composite outcome combining the occurrence of pneumonia, acute respiratory failure, unexpected mechanical ventilation, and pulmonary embolism within the first 30 postoperative days. Secondary outcomes were 30-day mortality, hospital length-of-stay, readmissions, and non-respiratory infections. The sample size was determined to have 90% power to identify a doubling of the primary outcome rate. Adjusted analyses were performed using propensity score modelling and inverse probability weighting. Findings: Of the 4928 patients assessed for the primary outcome, of whom 92.4% were vaccinated against the SARS-CoV-2, 705 had preoperative COVID-19. The primary outcome was reported in 140 (2.8%) patients. An 8-week preoperative COVID-19 was not associated with increased postoperative respiratory morbidity (odds ratio 1.08 [95% CI 0.48-2.13]; p = 0.83). None of the secondary outcomes differed between the two groups. Sensitivity analyses concerning the timing between COVID-19 and surgery, and the clinical presentations of preoperative COVID-19 did not show any association with the primary outcome, except for COVID-19 patients with ongoing symptoms the day of surgery (OR 4.29 [1.02-15.8]; p = 0.04). Interpretation: In our Omicron-predominant, highly immunised population undergoing general surgery, a preoperative COVID-19 was not associated with increased postoperative respiratory morbidity. Funding: The study was fully funded by the French Society of Anaesthesiology and Intensive Care Medicine (SFAR).

Hypotension Prediction Index Software to Prevent Intraoperative Hypotension during Major Non-Cardiac Surgery: Protocol for a European Multicenter Prospective Observational Registry (EU-HYPROTECT).

Background: Intraoperative hypotension is common in patients having non-cardiac surgery and associated with postoperative acute myocardial injury, acute kidney injury, and mortality. Avoiding intraoperative hypotension is a complex task for anesthesiologists. Using artificial intelligence to predict hypotension from clinical and hemodynamic data is an innovative and intriguing approach. The AcumenTM Hypotension Prediction Index (HPI) software (Edwards Lifesciences; Irvine, CA, USA) was developed using artificial intelligence­specifically machine learning­and predicts hypotension from blood pressure waveform features. We aimed to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery. Methods: We built up a European, multicenter, prospective, observational registry including at least 700 evaluable patients from five European countries. The registry includes consenting adults (≥18 years) who were scheduled for elective major non-cardiac surgery under general anesthesia that was expected to last at least 120 min and in whom arterial catheter placement and HPI monitoring was planned. The major objectives are to quantify and characterize intraoperative hypotension (defined as a mean arterial pressure [MAP] < 65 mmHg) when using HPI monitoring. This includes the time-weighted average (TWA) MAP < 65 mmHg, area under a MAP of 65 mmHg, the number of episodes of a MAP < 65 mmHg, the proportion of patients with at least one episode (1 min or more) of a MAP < 65 mmHg, and the absolute maximum decrease below a MAP of 65 mmHg. In addition, we will assess causes of intraoperative hypotension and investigate associations between intraoperative hypotension and postoperative outcomes. Discussion: There are only sparse data on the effect of using HPI monitoring on intraoperative hypotension in patients having elective major non-cardiac surgery. Therefore, we built up a European, multicenter, prospective, observational registry to describe the incidence, duration, severity, and causes of intraoperative hypotension when using HPI monitoring in patients having elective major non-cardiac surgery.

Medical economic study of outpatient versus inpatient surgical management of distal radius fractures.

INTRODUCTION: France aims to have more than 70% of its surgical procedures performed in an outpatient setting by 2022. HYPOTHESIS: The primary hypothesis of this study was that outpatient management of distal radius fractures with volar plating was more cost-effective than inpatient hospitalization. The secondary hypothesis was that more than 70% of these cases could be managed in an outpatient setting. MATERIALS AND METHODS: The series included 255 fractures that were operated on between February 2015 and February 2016. These were reviewed using 4 patient-specific criteria (age, ASA score, eligibility for an outpatient procedure, and anticoagulant therapy) and 4 injury-specific criteria (AO classification, open wound, nerve involvement, and other locations). Our outpatient rate was compared to the national rate and the net income was calculated according to the length of stay. RESULTS: Our series reported an outpatient rate of 77.25% with a mean age of 54years (19/95) and an inpatient rate of 22.75% with a mean age of 74 years (30/94). The national rate in 2018 was 34.8%. While outpatient procedures generated an operating profit of +€191.64, hospitalizations of 1 to 17 nights resulted in an operating loss. The overall economic assessment of the 255 fractures included in our series showed an operating loss of €22,113.78. DISCUSSION: Our primary hypothesis was confirmed since the outpatient management of distal radius fractures was more cost-effective than inpatient hospitalization. The secondary hypothesis was also confirmed since more than 70% of cases in our series were treated in an outpatient setting. CONCLUSION: Most distal radius fractures requiring a surgical intervention should be treated in an outpatient setting. LEVEL OF EVIDENCE: IV.

Influence of intraoperative vasopressor use on indocyanine green fluorescence angiography: first evaluation in an experimental model.

Intraoperative indocyanine green (ICG) fluorescence angiography has gained popularity and acceptance in many surgical fields for the real-time assessment of tissue perfusion. Although vasopressors have the potential to preclude an accurate assessment of tissue perfusion, there is a lack of literature with regards to its effect on ICG fluorescence angiography. An experimental porcine model was used to expose the small bowel for quantitative tissue perfusion assessment. Three increasing doses of norepinephrine infusion (0.1, 0.5, and 1.0 µg/kg/min) were administered intravenously over a 25-min interval. Time-to-peak fluorescence intensity (TTP) was the primary outcome. Secondary outcomes included absolute fluorescence intensity and local capillary lactate (LCL) levels. Five large pigs (mean weight: 40.3 ± 4.24 kg) were included. There was no significant difference in mean TTP (in seconds) at baseline (4.23) as compared to the second (3.90), third (4.41), fourth (4.60), and fifth ICG assessment (5.99). As a result of ICG accumulation, the mean and the maximum absolute fluorescence intensity were significantly different as compared to the baseline assessment. There was no significant difference in LCL levels (in mmol/L) at baseline (0.74) as compared to the second (0.82), third (0.64), fourth (0.60), and fifth assessment (0.62). Increasing doses of norepinephrine infusion have no significant influence on bowel perfusion using ICG fluorescence angiography.

A novel, automated, quantification of abnormal lung parenchyma in patients with COVID-19 infection: Initial description of feasibility and association with clinical outcome.

OBJECTIVE: Ground-glass opacities are the most frequent radiologic features of COVID-19 patients. We aimed to determine the feasibility of automated lung volume measurements, including ground-glass volumes, on the CT of suspected COVID-19 patients. Our goal was to create an automated and quantitative measure of ground-glass opacities from lung CT images that could be used clinically for diagnosis, triage and research. DESIGN: Single centre, retrospective, observational study. MEASUREMENTS: Demographic data, respiratory support treatment (synthetised in the maximal respiratory severity score) and CT-images were collected. Volume of abnormal lung parenchyma was measured with conventional semi-automatic software and with a novel automated algorithm based on voxels X-Ray attenuation. We looked for the relationship between the automated and semi-automated evaluations. The association between the ground-glass opacities volume and the maximal respiratory severity score was assessed. MAIN RESULTS: Thirty-seven patients were included in the main outcome analysis. The mean duration of automated and semi-automated volume measurement process were 15 (2) and 93 (41) min, respectively (p=8.05*10-8). The intraclass correlation coefficient between the semi-automated and automated measurement of ground-glass opacities and restricted normally aerated lung were both superior to 0.99. The association between the automated measured lung volume and the maximal clinical severity score was statistically significant for the restricted normally aerated (p=0.0097, effect-size: -385mL) volumes and for the ratio of ground-glass opacities/restricted normally aerated volumes (p=0.027, effect-size: 3.3). CONCLUSION: The feasibility and preliminary validity of automated impaired lung volume measurements in a high-density COVID-19 cluster was confirmed by our results.

Bayesian predictive probabilities: a good way to monitor clinical trials.

BACKGROUND: Bayesian methods, with the predictive probability (PredP), allow multiple interim analyses with interim posterior probability (PostP) computation, without the need to correct for multiple looks at the data. The objective of this paper was to illustrate the use of PredP by simulating a sequential analysis of a clinical trial. METHODS: We used data from the Laryngobloc trial that planned to include 480 patients to demonstrate the equivalence of success between a laryngoscopy performed with the Laryngobloc® device and a control device. A crossover Bayesian design was used. The success rates of the two laryngoscopy devices were compared. Interim analyses, computed from random numbers of subjects, were simulated. RESULTS: The PostP of equivalence rapidly reached the predefined bound of 0.95. The PredP computed with an equivalence margin of 10% reached the efficacy bound between 352 and 409 of the 480 included patients. If a frequentist analysis had been made on the basis of 217 out of 480 subjects, the study would have been prematurely stopped for equivalence. The PredP indicated that this result was nonetheless unstable and that the equivalence was, thus far, not guaranteed. CONCLUSIONS: Based on these interim analyses, we can conclude with a sufficiently high probability that the equivalence would have been met on the primary outcome before the predetermined end of this particular trial. If a Bayesian approach using PredP had been used, it would have allowed an early termination of the trial by reducing the calculated sample size by 15-20%.

Effects of Warmed and Humidified CO2 Surgical Site Insufflation in a Novel Experimental Model of Magnetic Compression Colonic Anastomosis.

Background. Pneumoperitoneum insufflation with warmed and humidified carbon dioxide (WH-CO2) can prevent heat loss and increase tissue oxygenation. We evaluated the impact of localized WH-CO2 insufflation on the anastomotic healing process. Methods. Sixty male Wistar rats were randomized: Group 1 (control, n = 12), Group 2 (cold and dry CO2, CD-CO2, n = 24), and Group 3 (WH-CO2, n = 24). A magnetic compression side-to-side colonic anastomosis was performed under 60-minute local abdominal CO2 flow insufflation. Animal temperature was recorded. IL-1, IL-6, and CRP levels were assessed before and after insufflation and on postoperative day (POD) 7 and POD 10. Endoscopic follow-up was performed on POD 7 and POD 10. A burst pressure (BP) test of the specimen was performed on POD 10, and histopathological analysis was then performed. Metabolomics of the anastomotic site was determined. Results. Seven rats (5 CD-CO2 group, 1 WH-CO2 group, and 1 control group) died during the survival period. Necropsies revealed intestinal occlusions (n = 2). One additional rat from the CD-CO2 group was sacrificed on POD 7 due to intestinal perforation. The postoperative course was uneventful in the remaining cases. There was no difference in BP among the groups. Thermal monitoring confirmed that WH-CO2 insufflation was effective to reduce heat loss. IL-1 levels were statistically and significantly lower on POD 10 in the WH-CO2 group than the CD-CO2 group but not lower than the control group. CRP levels, histopathology, and metabolomics did not show any difference between the 3 groups. Conclusions. WH-CO2 was effective to preserve core temperature. However, it did not improve anastomotic healing.

Surgical Support for Severe COVID-19 Patients: A Retrospective Cohort Study in a French High-Density COVID-19 Cluster.

Background. The COVID-19 epidemic has resulted in a massive surge in the need for intensive care unit (ICU) care. To avoid being overwhelmed, hospitals had to adapt and support the ICU teams in structured ICU care including involving surgical teams. This work aims at describing the collaborative efforts between the ICU care team and the Surgical Task Force (STF) during a surge of ICU activity in a University Hospital in a French high-density COVID-19 cluster. Study Design. This retrospective single center study analyzed the STF workflow and the ICU population. The study included 55 patients hospitalized in our ICU, ICU-converted step-down units, and post-anesthesia care units. The primary measure was the global daily STF activity. The secondary measure was the daily activity for each of the 5 tasks accomplished by the STF. Results. The STF attempted 415 phone calls for 55 patients' families, 237 mobilizations of patients requiring prone positions, follow-up of 20 patients requiring medevac, and contribution to ethical discussion for 2 patients. The mean (SD) daily number of successful phones calls, ethical discussions, mobilizations of patients requiring prone positions and medevac follow-up were 18 (7), .1 (.4), 10 (7), and 2 (3), respectively. No actions for discharge summaries writing were required. The maximum number of daily mobilizations for patients requiring prone positions was 25. The maximum number of daily attempted phone calls and successful phone calls were 37 and 26, respectively. Conclusion. Surgeons' technical and nontechnical skills represented an effective support for ICU teams during the COVID-19 pandemic.

Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population.

BACKGROUND: Quality of recovery is an important component of perioperative health status. The 15-item Quality of Recovery (QoR-15) scale is a validated multidimensional questionnaire that measures postoperative quality of recovery. The aim of this study was to translate and assess the psychometric properties of a French version of the QoR-15 scale (QoR-15F) to measure postoperative recovery in French-speaking patients. METHODS: After translation into French of the original English version of the QoR-15 scale, psychometric validation of the QoR-15F scale to measure postoperative quality of recovery was performed. This psychometric validation included validity, reliability, responsiveness, and feasibility. The QoR-15F scale was administered before operation and on Postoperative day 1 in French-speaking patients. Patient-perceived global recovery assessment was measured at Postoperative day 1 using a VAS. RESULTS: We enrolled 150 patients, and 144 completed the study protocol. The completion rate of administered questionnaires was 100%. Pearson (r) correlation between postoperative QoR-15F and the global recovery assessment by the patient was 0.60 (P<0.0001). As expected, there was a significant negative correlation between QoR-15F score and duration of surgery (r=-0.29; P<0.01), duration of PACU stay (r=-0.21; P=0.01), and duration of hospital stay (r=-0.34; P<0.01). Cronbach's alpha was 0.81, split-half alpha was 0.83, and the global test-retest intra-class coefficient was 0.98 (0.95-0.99). CONCLUSIONS: The QoR-15F is a valid and reliable tool to measure postoperative quality of recovery in French-speaking patients. The psychometric properties to measure postoperative quality of recovery were similar to the seminal English version. CLINICAL TRIAL REGISTRATION: NCT03578068.

Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients.

BACKGROUND: Acute respiratory distress syndrome continues to drive significant morbidity and mortality after severe trauma. The incidence of trauma-induced, moderate-to-severe hypoxaemia, according to the Berlin definition, could be as high as 45%. Its pathophysiology includes the release of damage-associated molecular patterns (DAMPs), which propagate tissue injuries by triggering neutrophil extracellular traps (NETs). NETs include a DNA backbone coated with cytoplasmic proteins, which drive pulmonary cytotoxic effects. The structure of NETs and many DAMPs includes double-stranded DNA, which prevents their neutralization by plasma. Dornase alfa is a US Food and Drug Administration-approved recombinant DNase, which cleaves extracellular DNA and may therefore break up the backbone of NETs and DAMPs. Aerosolized dornase alfa was shown to reduce trauma-induced lung injury in experimental models and to improve arterial oxygenation in ventilated patients. METHODS: TRAUMADORNASE will be an institution-led, multicentre, double-blinded, placebo-controlled randomized trial in ventilated trauma patients. The primary trial objective is to demonstrate a reduction in the incidence of moderate-to-severe hypoxaemia in severe trauma patients during the first 7 days from 45% to 30% by providing aerosolized dornase alfa as compared to placebo. The secondary objectives are to demonstrate an improvement in lung function and a reduction in morbidity and mortality. Randomization of 250 patients per treatment arm will be carried out through a secure, web-based system. Statistical analyses will include a descriptive step and an inferential step using fully Bayesian techniques. The study was approved by both the Agence Nationale de la Sécurité du Médicament et des Produits de Santé (ANSM, on 5 October 2018) and a National Institutional Review Board (CPP, on 6 November 2018). Participant recruitment began in March 2019. Results will be published in international peer-reviewed medical journals. DISCUSSION: If early administration of inhaled dornase alfa actually reduces the incidence of moderate-to-severe hypoxaemia in patients with severe trauma, this new therapeutic strategy may be easily implemented in many clinical trauma care settings. This treatment may facilitate ventilator weaning, reduce the burden of trauma-induced lung inflammation and facilitate recovery and rehabilitation in severe trauma patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03368092. Registered on 11 December 2017.

Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial.

Importance: It is not known if use of colloid solutions containing hydroxyethyl starch (HES) to correct for intravascular deficits in high-risk surgical patients is either effective or safe. Objective: To evaluate the effect of HES 130/0.4 compared with 0.9% saline for intravascular volume expansion on mortality and postoperative complications after major abdominal surgery. Design, Setting, and Participants: Multicenter, double-blind, parallel-group, randomized clinical trial of 775 adult patients at increased risk of postoperative kidney injury undergoing major abdominal surgery at 20 university hospitals in France from February 2016 to July 2018; final follow-up was in October 2018. Interventions: Patients were randomized to receive fluid containing either 6% HES 130/0.4 diluted in 0.9% saline (n = 389) or 0.9% saline alone (n = 386) in 250-mL boluses using an individualized hemodynamic algorithm during surgery and for up to 24 hours on the first postoperative day, defined as ending at 7:59 am the following day. Main Outcomes and Measures: The primary outcome was a composite of death or major postoperative complications at 14 days after surgery. Secondary outcomes included predefined postoperative complications within 14 days after surgery, durations of intensive care unit and hospital stays, and all-cause mortality at postoperative days 28 and 90. Results: Among 826 patients enrolled (mean age, 68 [SD, 7] years; 91 women [12%]), 775 (94%) completed the trial. The primary outcome occurred in 139 of 389 patients (36%) in the HES group and 125 of 386 patients (32%) in the saline group (difference, 3.3% [95% CI, -3.3% to 10.0%]; relative risk, 1.10 [95% CI, 0.91-1.34]; P = .33). Among 12 prespecified secondary outcomes reported, 11 showed no significant difference, but a statistically significant difference was found in median volume of study fluid administered on day 1: 1250 mL (interquartile range, 750-2000 mL) in the HES group and 1500 mL (interquartile range, 750-2150 mL) in the saline group (median difference, 250 mL [95% CI, 83-417 mL]; P = .006). At 28 days after surgery, 4.1% and 2.3% of patients had died in the HES and saline groups, respectively (difference, 1.8% [95% CI, -0.7% to 4.3%]; relative risk, 1.76 [95% CI, 0.79-3.94]; P = .17). Conclusions and Relevance: Among patients at risk of postoperative kidney injury undergoing major abdominal surgery, use of HES for volume replacement therapy compared with 0.9% saline resulted in no significant difference in a composite outcome of death or major postoperative complications within 14 days after surgery. These findings do not support the use of HES for volume replacement therapy in such patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02502773.

Validation of MRI for Volumetric Quantification of Atelectasis in the Perioperative Period: An Experimental Study in Swine.

Background: Impairment of pulmonary aeration is a frequent postoperative complication that is associated with adverse outcome. Diagnosis and quantification of impaired pulmonary aeration by CT scan is limited due to concern for exposure to ionizing radiation. Magnetic resonance imaging (MRI) represents a potential radiation-free alternative for this use. We undertook an experimental study to validate the use of MRI to quantify pulmonary aeration impairment. Methods: Ten large white pigs were studied before intubation, after intubation, 2 h after non-protective mechanical ventilation and after intra-tracheal negative pressure suction to induce atelectasis. A lung CT scan immediately followed by a lung MRI were performed at all four time points. On the 40 CT images lung volumes corresponding to non-aerated, poorly aerated, normally aerated, and overinflated voxels were measured based on their radiodensity. Similarly, on the 40 MRI images lung volumes corresponding to non-aerated and aerated voxels were measured based on their signal intensity. The correlation between non-aerated lung by MRI vs., CT scans, and with PaO2/FiO2 measured at each of the four time points was assessed with the Pearson' correlation coefficient, bias and limits of agreement. Results: Pearson correlation coefficient, bias and limits of agreements between the CT non-aerated lung volumes and MRI abnormal lung volumes were 0.88, -16 ml, and (-108, 77), respectively. Pearson correlation coefficient between PaO2/FiO2 and abnormal lung volumes measured with MRI was -0.60. Conclusion: In a preclinical swine model, quantitative measurements of pulmonary atelectasis by MRI-imaging are well correlated with the gold standard, i.e., densitometric scan CT measurements.

Efficacy of acupressure on quality of recovery after surgery: Randomised controlled trial.

BACKGROUND: Acupressure therapy is associated with favourable efficacies on postoperative nausea, pain and sleep disturbance, although the quality of the evidence is generally low. No randomised clinical trial has yet assessed the effect of acupressure on postoperative quality of recovery (QoR). OBJECTIVE: The objective was to study acupressure efficacy on patient-reported postoperative recovery. DESIGN: We conducted a single centre, three-group, blind, randomised controlled, pragmatic trial assessing acupressure therapy on the PC6, LI4 and HT7 acupoints. PATIENTS: Postoperative patients expected to stay in hospital at least 2 days after surgery. INTERVENTIONS: In the acupressure group, pressure was applied for 6 min (2 min per acupoint), three times a day after surgery for a maximum of 2 postoperative days during the hospital stay. In the sham group, extremely light touch was applied to the acupoints. The third group did not receive any touch. MAIN OUTCOME MEASURES: The primary outcome was the change in the QoR, using the QoR-15 questionnaire, between postoperative days 1 and 3. Key secondary outcomes included patients' satisfaction, postoperative nausea and vomiting, pain score and opioid (morphine equivalent) consumption. Assessors for the primary and secondary endpoints were blind to the group allocation. RESULTS: Overall, 163 patients were randomised (acupressure n=55, sham n=53, no intervention n=55). The mean (SD) postoperative change in QoR-15 did not differ statistically (P = 0.27) between the acupressure, sham and no intervention groups: 15.2 (17.8), 14.2 (21.9), 9.2 (21.7), respectively. Patient satisfaction (on a 0 to 10 scale) was statistically different (P = 0.01) among these three groups: 9.1 (1.5), 8.4 (1.6) and 8.2 (2.2), respectively. Changes in pain score and morphine equivalent consumption were not significantly different between the groups. CONCLUSION: Two days of postoperative acupressure therapy (up to six treatments) did not significantly improve patient QoR, postoperative nausea and vomiting, pain score or opioid consumption. Acupressure, however, was associated with improved patient satisfaction. TRIAL REGISTRATION: ClinicalTrials.gov, identifier: NCT02762435.

The impact of warmed and humidified CO2 insufflation during robotic radical prostatectomy: Results of a randomized controlled trial.

BACKGROUND: Cool and dry gas insufflation during laparoscopy induces hypothermia and cytokine increase, with significant perioperative morbidity. Our aim was to assess if warmed and humidified CO2 insufflation with HumiGard™ device can achieve significant benefits over standard insufflation in terms of risk of hypothermia, cytokine response, blood gases, and intra- and postoperative parameters, in the setting of robot-assisted radical prostatectomy (RARP). METHODS: This was a prospective, randomized controlled clinical trial. Sixty-four patients with prostate cancer undergoing RARP were randomized to receive warmed and humidified CO2 insufflation with HumiGard device, plus hot air warming blanket (treatment group, H + WB), or standard CO2 insufflation, plus hot air warming blanket (control group, WB). Body core temperature (BCT), plasma levels of IL-6 and TNF-α, pain scores, and intraoperative parameters were recorded. The data were analyzed according to the Bayesian paradigm. RESULTS: Intraoperative BCT increased in both groups during surgery, with a statistically significant difference favoring group H + WB, ending at 0.2°C higher on average than group WB. No difference across groups was shown for cytokine levels. Blood gas parameters were not affected by warmed CO2 insufflation. No statistical differences were noted for pain scores and the other intra- and postoperative parameters. CONCLUSIONS: During RARP, warm and humidified CO2 insufflation with the HumiGard device was more effective than the standard CO2 insufflation in maintaining the patient's heat homeostasis, even if the difference was minimal. No imbalances were detected on blood gas analyses. No benefit could be shown in terms of cytokine levels and pain scores.