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Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.

ABSTRACT: INTRODUCTION:Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO2) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume and improves gas exchange, and therefore it may increase the partial pressure of tissue oxygen for a given FIO2. The trial presented here aims to compare the efficacy of high versus conventional FIO2 in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation. METHODS AND ANALYSIS:This is a comparative, prospective, multicentre, randomised and controlled two-arm trial that will include 756 patients scheduled for abdominal surgery. The patients will be randomised into two groups: (1) a high FIO2 group (80% oxygen; FIO2 of 0.80) and (2) a conventional FIO2 group (30% oxygen; FIO2 of 0.30). Each group will be assessed intra- and postoperatively. The primary outcome is the appearance of postoperative SSI complications. Secondary outcomes are the appearance of systemic and pulmonary complications. ETHICS AND DISSEMINATION:The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario in Valencia). Informed consent will be obtained from all patients before their participation. If the approach using high FIO2 during individualised open-lung ventilation decreases SSIs, use of this method will become standard practice for patients scheduled for future abdominal surgery. Publication of the results is anticipated in early 2019. TRIAL REGISTRATION NUMBER:NCT02776046; Pre-results.

SUBMITTER: Ferrando C

PROVIDER: S-EPMC5642673 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.

Ferrando Carlos C Soro Marina M Unzueta Carmen C Canet Jaume J Tusman Gerardo G Suarez-Sipmann Fernando F Librero Julian J Peiró Salvador S Pozo Natividad N Delgado Carlos C Ibáñez Maite M Aldecoa César C Garutti Ignacio I Pestaña David D Rodríguez Aurelio A García Del Valle Santiago S Diaz-Cambronero Oscar O Balust Jaume J Redondo Francisco Javier FJ De La Matta Manuel M Gallego Lucía L Granell Manuel M Martínez Pascual P Pérez Ana A Leal Sonsoles S Alday Kike K García Pablo P Monedero Pablo P Gonzalez Rafael R Mazzinari Guido G Aguilar Gerardo G Villar Jesús J Belda Francisco Javier FJ

BMJ open 20170731 7

<h4>Introduction</h4>Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO<sub>2</sub>) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume a ...[more]

PMID: 28760799

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Project description:Guidelines from the World Health Organization strongly recommend the use of a high fraction of inspired oxygen (FiO2) in adult patients undergoing general anesthesia to reduce surgical site infection (SSI). However, previous meta-analyses reported inconsistent results. We aimed to address this controversy by focusing specifically on abdominal surgery with relatively high risk of SSI. Medline, EMBASE, and Cochrane CENTRAL databases were searched. Randomized trials of abdominal surgery comparing high to low perioperative FiO2 were included, given that the incidence of SSI was reported as an outcome. Meta-analyses of risk ratios (RR) were performed using a fixed effects model. Subgroup analysis and meta-regression were employed to explore sources of heterogeneity. We included 27 trials involving 15977 patients. The use of high FiO2 significantly reduced the incidence of SSI (n = 27, risk ratio (RR): 0.87; 95% confidence interval (CI): 0.79, 0.95; I2 = 49%, Z = 3.05). Trial sequential analysis (TSA) revealed that z-curve crossed the trial sequential boundary and data are sufficient. This finding held true for the subgroup of emergency operations (n = 2, RR: 0.54; 95% CI: 0.35, 0.84; I2 = 0%, Z = 2.75), procedures using air as carrier gas (n = 9, RR: 0.79; 95% CI: 0.69, 0.91; I2 = 60%, Z = 3.26), and when a high level of FiO2 was maintained for a postoperative 6 h or more (n = 9, RR: 0.68; 95% CI: 0.56, 0.83; I2 = 46%, Z = 3.83). Meta-regression revealed no significant interaction between SSI with any covariates including age, sex, body-mass index, diabetes mellitus, duration of surgery, and smoking. Quality of evidence was assessed to be moderate to very low. Our pooled analysis revealed that the application of high FiO2 reduced the incidence of SSI after abdominal operations. Although TSA demonstrated sufficient data and cumulative analysis crossed the TSA boundary, our results should be interpreted cautiously given the low quality of evidence.Registration: https://www.crd.york.ac.uk/prospero (CRD42022369212) on October 2022.

Project description:BackgroundA recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdominal pressure in most patients. The multifaceted strategy, focused on lower to individualised intra-abdominal pressures, includes prestretching the abdominal wall during initial insufflation, deep neuromuscular blockade, low tidal volume ventilation settings and a modified lithotomy position. The study presented here tests the hypothesis that this strategy improves outcomes of patients scheduled for colorectal laparoscopic surgery.MethodsThe Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery versus Standard Therapy (IPPCollapse-II) study is a multicentre, two-arm, parallel-group, single-blinded randomised 1:1 clinical study that runs in four academic hospitals in Spain. Patients scheduled for colorectal laparoscopic surgery with American Society of Anesthesiologists classification I to III who are aged > 18 years and are without cognitive deficits are randomised to an individualised pneumoperitoneum pressure strategy (the intervention group) or to a conventional pneumoperitoneum pressure strategy (the control group). The primary outcome is recovery assessed with the Post-operative Quality of Recovery Scale (PQRS) at postoperative day 1. Secondary outcomes include PQRS score in the post anaesthesia care unit and at postoperative day 3, postoperative complications until postoperative day 28, hospital length of stay and process-related outcomes.DiscussionThe IPPCollapse-II study will be the first randomised clinical study that assesses the impact of an individualised pneumoperitoneum pressure strategy focused on working with the lowest intra-abdominal pressure during colorectal laparoscopic surgery on relevant patient-centred outcomes. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance for optimising the care and safety of laparoscopic abdominal surgery. Selection of patient-reported outcomes as the primary outcome of this study facilitates the translation into clinical practice. Access to source data will be made available through anonymised datasets upon request and after agreement of the Steering Committee of the IPPCollapse-II study.Trial registrationClinicalTrials.gov, NCT02773173 . Registered on 16 May 2016. EudraCT, 2016-001693-15. Registered on 8 August 2016.

Project description:Protective ventilation is associated with a lower incidence of pulmonary complications. However, there are few published data on routine pulmonary management in adult cardiac surgery. The present study's primary objective was to survey pulmonary management in this high-risk population, as practiced by anesthesiologists in France. All 460 registered France-based cardiac anesthesiologists were invited (by e-mail) to participate in an online survey in January-February 2015. The survey's questionnaire was designed to assess current practice in pre-, per-, and postoperative pulmonary management. In all, 198 anesthesiologists (43% of those invited) participated in the survey. Other than during the cardiopulmonary bypass (CPB) per se, 179 anesthesiologists (91% of respondees) [95% confidence interval (CI): 87-95] used a low-tidal-volume approach (6-8 mL/kg), whereas techniques based on positive end-expiratory pressure and recruitment maneuvers vary greatly from 1 anesthesiologist to another. During CPB, 104 (53%) [95% CI: 46-60] anesthesiologists withdrew mechanical ventilation (with disconnection, in some cases) and 97 (49%) [95% CI: 42-56] did not prescribe positive end-expiratory pressure. One hundred sixty-five (83%) [95% CI: 78-88] anesthesiologists stated that a written protocol for peroperative pulmonary management was not available. Twenty (10%) [95% CI: 6-14] and 11 (5%) [95% CI: 2-8] anesthesiologists stated that they did use protocols for ventilator use and recruitment maneuvers, respectively. The preoperative period (pulmonary examinations and prescription of additional assessments) and the postoperative period (extubation, and noninvasive ventilation) periods vary greatly from 1 anesthesiologist to another. The great majority of French cardiac anesthesiologists use a low tidal volume during cardiac surgery (other than during CPB per se). However, pulmonary management procedures varied markedly from 1 anesthesiologist to another. There is a clear need for large clinical studies designed to identify best practice in pulmonary management.

Dataset Information

Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.

Publications

Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.

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