Data integrity issues: catalyst for a more robust approach to research on perioperative oxygen therapy? (original) (raw)
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British Journal of Anaesthesia, 2019
Background: In 2016, the World Health Organization (WHO) strongly recommended the use of a high fraction of inspired oxygen (FiO 2) in adult patients undergoing general anaesthesia to reduce the risk of surgical site infection (SSI). Since then, further trials have been published, trials included previously have come under scrutiny, and one article was retracted. We updated the systematic review on which the recommendation was based. Methods: We performed a systematic literature search from January 1990 to April 2018 for RCTs comparing the effect of high (80%) vs standard (30e35%) FiO 2 on the incidence of SSI. Studies retracted or under investigation were excluded. A random effects model was used for meta-analyses; the sources of heterogeneity were explored using meta-regression. Results: Of 21 RCTs included, six were newly identified since the publication of the WHO guideline review; 17 could be included in the final analyses. Overall, no evidence for a reduction of SSI after the use of high FiO 2 was found [relative risk (RR): 0.89; 95% confidence interval (CI): 0.73e1.07]. There was evidence that high FiO 2 was beneficial in intubated patients [RR: 0.80 (95% CI: 0.64e0.99)], but not in non-intubated patients [RR: 1.20 (95% CI: 0.91e1.58); test of interaction; P¼0.048]. Conclusions: The WHO updated analyses did not show definite beneficial effect of the use of high perioperative FiO 2 , overall, but there was evidence of effect of reducing the SSI risk in surgical patients under general anaesthesia with tracheal intubation. However, the evidence for this beneficial effect has become weaker and the strength of the recommendation needs to be reconsidered.
British Journal of Anaesthesia, 2019
Background: Evidence-based guidelines from the World Health Organization (WHO) have recommended a high (80%) fraction of inspired oxygen (FiO 2) to reduce surgical site infection in adult surgical patients undergoing general anaesthesia with tracheal intubation. However, there is ongoing debate over the safety of high FiO 2. We performed a systematic review to define the relative risk of clinically relevant adverse events (AE) associated with high FiO 2. Methods: We reviewed potentially relevant articles from the WHO review supporting the recommendation, including an updated (July 2018) search of EMBASE and PubMed for randomised and non-randomised controlled studies reporting AE in surgical patients receiving 80% FiO 2 compared with 30e35% FiO 2. We assessed study quality and performed meta-analyses of risk ratios (RR) comparing 80% FiO 2 against 30e35% for major complications, mortality, and intensive care admission. Results: We included 17 moderateegood quality trials and two non-randomised studies with serious-critical risk of bias. No evidence of harm with high FiO 2 was found for major AE in the meta-analysis of randomised trials: atelectasis RR 0.91 [95% confidence interval (CI) 0.59e1.42); cardiovascular events RR 0.90 (95% CI 0.32e2.54); intensive care admission RR 0.93 (95% CI 0.7e1.12); and death during the trial RR 0.49 (95% CI 0.17e1.37). One non-randomised study reported that high FiO 2 was associated with major respiratory AE [RR 1.99 (95% CI 1.72e2.31)]. Conclusions: No definite signal of harm with 80% FiO 2 in adult surgical patients undergoing general anaesthesia was demonstrated and there is little evidence on safety-related issues to discourage its use in this population.
Colombian Journal of Anesthesiology, 2012
To evaluate the effectiveness and safety of oxygen supplementation (inspired fraction of oxygen, FiO2) in high concentrations versus low concentrations, given with the aim of reducing complications in patients undergoing surgical procedures under general anesthesia. Methods: A systematic review and a meta-analysis were performed following the methodology proposed by the Cochrane Collaboration. The review included controlled clinical trials conducted in patients undergoing surgical procedures under general anesthesia. After conducting data base searches (PUBMED, CENTRAL y LILACS), and once the relevant studies were identified, additional snowballing ambispective and grey literature searches were done. Results: Of the 17 clinical trials finally included (4844 patients), 7 were considered to a have a low risk of bias. High FiO2 levels reduce post-operative nausea and vomiting only in surgeries with extensive intestinal manipulation (odds ratio [OR] 0.40; 95% confidence interval [CI] , 0.20 to 0.80). In this same clinical setting, the risk of surgical site infection (OR 0.46; 95% CI, 0.29 to 0.74), and mortality (OR 0.17; 95% CI, 0.03 to 0.99) are also reduced. There was no impact on the need for rescue anti-emetic administration, length of stay in the post-anesthetic care unit, unexpected admission to the intensive care unit, or postoperative hospital stay in any of the surgical populations. Conclusions: Intra-operative oxygen supplementation in high concentrations (≥ 60%) might reduce the risk of surgical site infection and mortality in surgeries with extensive intestinal manipulation
Effect of Applying Perioperative Oxygen Therapy Guidelines on Postoperative Health Outcomes
Egyptian Journal of Health Care, 2022
Background, Pulmonary complications are most common complications in postoperative period leading to increased mortality rate. The incidence of postoperative hypoxemia is particularly high in surgical patients. Aim, was to evaluate the effect of applying perioperative oxygen therapy guidelines on postoperative outcomes. Methodology, Quasiexperimental study with a purposive sample of 90 surgical patients from both gender who were admitted to surgical ward at Mansoura University Hospital was enrolled in this study. Patients were assigned to control and intervention group. Data were collected using three tools: An interviewing questionnaire sheet, National Early Warning Score (NEWS), and ASEPSIS. Results, there was a significant decrease in postoperative hypoxemia, improved wound healing with decreased wound infection rate in the study group compared to control group according to the NEWS and ASEPSIS Scale (p-value ≤ 0.05). Conclusion, the study concluded that application of postoperative O2 therapy guidelines have a significant effect in reducing postoperative hypoxemia, improved wound healing with decreased wound infection rate. Recommendations, standardized O2 therapy guidelines should be applied at surgical words for nurses in order to help in decreasing the rate of postoperative hypoxemia.
The Lancet Respiratory Medicine, 2015
Background Morbidity after major surgery is associated with low oxygen delivery. Haemodynamic therapy aimed at increasing oxygen delivery in an eff ort to reduce oxygen debt, tissue injury, and morbidity, is controversial. The most appropriate target for this strategy is unclear and might have several off-target eff ects, including loss of neural (parasympathetic)-mediated cellular protection. We hypothesised that individualised oxygen delivery targeted haemodynamic therapy (goal-directed therapy) in high-risk surgical patients would reduce postoperative morbidity, while secondarily addressing whether goal-directed therapy aff ected parasympathetic function. Methods In this multicentre, randomised, double-blind, controlled trial, adult patients undergoing major elective surgery were allocated by computer-generated randomisation to a postoperative protocol (fl uid, with and without dobutamine) targeted to achieve their individual preoperative oxygen delivery value (goal-directed therapy) or standardised care (control). Patients and staff were masked to the intervention. The primary outcome was absolute risk reduction (ARR) in morbidity (defi ned by Clavien-Dindo grade II or more) on postoperative day 2. We also assessed a secondary outcome focused on parasympathetic function, using time-domain heart rate variability measures. Analyses were done on an intention-to-treat basis. The trial was registered with Controlled Clinical Trials (number ISRCTN76894700). Findings We enrolled 204 patients between May 20, 2010, and Feb 12, 2014. Intention-to-treat analysis of the 187 (92%) patients who completed the trial intervention period showed that early morbidity was similar between goal-directed therapy (44 [46%] of 95 patients) and control groups (49 [53%] of 92 patients) (ARR-7%, 95% CI-22 to 7; p=0•30). Prespecifi ed secondary analysis showed that 123 (66%) of 187 patients achieved preoperative oxygen delivery (irrespective of intervention). These patients sustained less morbidity (ARR 19%, 95% CI 3-34; p=0•016), including less infectious complications. Goal-directed therapy reduced parasympathetic activity postoperatively (relative risk 1•33, 95% CI 1•01-1•74). Interpretation Achievement of preoperative oxygen delivery values in the postoperative phase was associated with less morbidity, but this was not aff ected by the use of an oxygen delivery targeted strategy. Reduced parasympathetic activity after goal-directed therapy was associated with the failure of this intervention to reduce postoperative morbidity.
Tissue oxygenation as a target for goal-directed therapy in high-risk surgery: a pilot study
BMC anesthesiology, 2014
Tissue hypoperfusion occurs frequently during surgery and may contribute to postoperative organ dysfunction. There is a need for perioperative treatment protocols aiming at improving tissue oxygenation (StO2). We hypothesised that intra-operative optimisation of StO2 improves tissue perfusion and thus reduces postoperative complications. Furthermore, we evaluated the feasibility of the optimisation algorithm used. We randomized 50 high-risk patients, all >65 years with ASA physical status III, who underwent major abdominal surgery under standardized balanced general anesthesia combined with epidural analgesia. Throughout surgery StO2 was monitored at the thenar eminence using near-infrared spectroscopy. All patients were treated according to a standard care algorithm. In addition, patients in the intervention group were treated with dobutamine if necessary to keep or raise StO2 ≥ 80%. Data were recorded continuously and complications were recorded during hospital stay with a maxi...