Dataset Information

Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

ABSTRACT: A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receiving FiO(2) = 0.80. It has not been settled if a high inspiratory oxygen fraction increases the risk of pulmonary complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery.The PROXI-Trial is a randomized, patient- and assessor blinded trial of perioperative supplemental oxygen in 1400 patients undergoing acute or elective laparotomy in 14 Danish hospitals. Patients are randomized to receive either 80% oxygen (FiO(2) = 0.80) or 30% oxygen (FiO(2) = 0.30) during surgery and for the first 2 postoperative hours. The primary outcome is surgical site infection within 14 days. The secondary outcomes are: atelectasis, pneumonia, respiratory failure, re-operation, mortality, duration of postoperative hospitalization, and admission to intensive care unit. The sample size allows detection of a 33% relative risk reduction in the primary outcome with 80% power.This trial assesses benefits and harms of a high inspiratory oxygen fraction, and the trial may be generalizable to a general surgical population undergoing laparotomy.ClinicalTrials.gov identifier: NCT00364741.

SUBMITTER: Meyhoff CS

PROVIDER: S-EPMC2600782 | biostudies-literature | 2008 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

Meyhoff Christian S CS Wetterslev Jørn J Jorgensen Lars N LN Henneberg Steen W SW Simonsen Inger I Pulawska Therese T Walker Line R LR Skovgaard Nina N Heltø Kim K Gocht-Jensen Peter P Carlsson Palle S PS Rask Henrik H Karim Sharaf S Carlsen Charlotte G CG Jensen Frank S FS Rasmussen Lars S LS

Trials 20081022

<h4>Background</h4>A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk of surgical site infections after elective colorectal surgery, but a third trial was stopped early because the frequency of surgical site infections was more than doubled in the group receivi ...[more]

PMID: 18945347

Similar Datasets

Project description:BACKGROUND:Vitreoretinal surgery in anticoagulated patients is a challenging situation for vitreoretinal surgeons, who have to choose between being faced with the systemic thromboembolic risks that the interruption of anticoagulation involves, or the intra- and postoperative haemorrhagic risks associated with maintenance of this therapy. So far, no trial has compared, in a prospective and randomized manner, perioperative complications and the visual results associated with continuation or interruption of oral anticoagulant therapy before pars plana vitrectomy (PPV) under retrobulbar anaesthesia. The main objective of this trial is to compare haemostasis-related perioperative complications of PPV in patients maintaining anticoagulant therapy before surgery compared to patients with an interruption in this therapy before surgery. METHODS:Ninety-six patients will be randomly assigned to either the control group, in whom oral anticoagulant therapy will be interrupted and substituted with subcutaneous heparin according to local clinical practice, or the intervention group in whom oral anticoagulant therapy will not be interrupted before surgery. Patients will be stratified according to the oral anticoagulant they were taking (direct or indirect anticoagulation). They will be followed up for 12?weeks, and the primary outcome, and haemorrhagic complications until 15?days after surgery, will be evaluated. DISCUSSION:This trial will provide novel information on the possibility of continuing anticoagulant therapy during PPV. The benefits expected from the change in the current surgical management paradigm for anticoagulated patients would be a decreased risk in the incidence of perioperative thromboembolic events and the possibility of performing surgery without delay and without the need for patients to change their usual anticoagulation protocol to the more complex and less safe substitutive therapy. TRIAL REGISTRATION:Clinical Trials Register EudraCT, 2018-000753-45. Registered on 11 November 2018.

Project description:Background:Postoperative pulmonary complications (PPCs) contribute significantly to overall postoperative morbidity and mortality. In abdominal surgery, PPCs remain frequent. The study aimed to analyze the profile and outcomes of PPCs in patients submitted to abdominal surgery and admitted in a Portuguese polyvalent intensive care unit. Methods:From January to December 2017 in the polyvalent intensive care unit of Hospital Garcia de Orta, Almada, Portugal, we conducted a retrospective, observational study of inpatients submitted to urgent or elective abdominal surgery who had severe PPCs. We evaluated the perioperative risk factors and associated mortality. Logistic regression was performed to find which perioperative risk factors were most important in the occurrence of PPCs. Results:Sixty patients (75% male) with a median age of 64.5 [47-81] years who were submitted to urgent or elective abdominal surgery were included in the analysis. Thirty-six patients (60%) developed PPCs within 48?h and twenty-four developed PPCs after 48?h. Pneumonia was the most frequent PPC in this sample. In this cohort, 48 patients developed acute respiratory failure and needed mechanical ventilation. In the emergency setting, peritonitis had the highest rate of PPCs. Electively operated patients who developed PPCs were mostly carriers of digestive malignancies. Thirty-day mortality was 21.7%. The risk of PPCs development in the first 48?h was related to the need for neuromuscular blocking drugs several times during surgery and preoperative abnormal arterial blood gases. Median abdominal surgical incision, long surgery duration, and high body mass index were associated with PPCs that occurred more than 48?h after surgery. The American Society of Anesthesiologists physical status score 4 and COPD/Asthma determined less mechanical ventilation needs since they were preoperatively optimized. Malnutrition (low albumin) before surgery was associated with 30-day mortality. Conclusion:PPCs after abdominal surgery are still a major problem since they have profound effects on outcomes. Our results suggest that programs before surgery, involve preoperative lifestyle changes, such as nutritional supplementation, exercise, stress reduction, and smoking cessation, were an effective strategy in mitigating postoperative complications by decreasing mortality.

Project description:BackgroundPostoperative pulmonary complications (PPCs) have an impact on the recovery of adults after surgery. It is therefore important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify adults who might benefit from respiratory rehabilitation.ObjectivesOur primary objective was to assess the effectiveness of preoperative inspiratory muscle training (IMT) on PPCs in adults undergoing cardiac or major abdominal surgery. We looked at all-cause mortality and adverse events.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to October 2014), EMBASE (1980 to October 2014), CINAHL (1982 to October 2014), LILACS (1982 to October 2014), and ISI Web of Science (1985 to October 2014). We did not impose any language restrictions.Selection criteriaWe included randomized controlled trials that compared preoperative IMT and usual preoperative care for adults undergoing cardiac or major abdominal surgery.Data collection and analysisTwo or more review authors independently identified studies, assessed trial quality, and extracted data. We extracted the following information: study characteristics, participant characteristics, intervention details, and outcome measures. We contacted study authors for additional information in order to identify any unpublished data.Main resultsWe included 12 trials with 695 participants; five trials included participants awaiting elective cardiac surgery and seven trials included participants awaiting elective major abdominal surgery. All trials contained at least one domain judged to be at high or unclear risk of bias. Of greatest concern was the risk of bias associated with inadequate blinding, as it was impossible to blind participants due to the nature of the study designs. We could pool postoperative atelectasis in seven trials (443 participants) and postoperative pneumonia in 11 trials (675 participants) in a meta-analysis. Preoperative IMT was associated with a reduction of postoperative atelectasis and pneumonia, compared with usual care or non-exercise intervention (respectively; risk ratio (RR) 0.53, 95% confidence interval (CI) 0.34 to 0.82 and RR 0.45, 95% CI 0.26 to 0.77). We could pool all-cause mortality within postoperative period in seven trials (431 participants) in a meta-analysis. However, the effect of IMT on all-cause postoperative mortality is uncertain (RR 0.40, 95% CI 0.04 to 4.23). Eight trials reported the incidence of adverse events caused by IMT. All of these trials reported that there were no adverse events in both groups. We could pool the mean duration of hospital stay in six trials (424 participants) in a meta-analysis. Preoperative IMT was associated with reduced length of hospital stay (MD -1.33, 95% CI -2.53 to -0.13). According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group guidelines for evaluating the impact of healthcare interventions, the overall quality of studies for the incidence of pneumonia was moderate, whereas the overall quality of studies for the incidence of atelectasis, all-cause postoperative death, adverse events, and duration of hospital stay was low or very low.Authors' conclusionsWe found evidence that preoperative IMT was associated with a reduction of postoperative atelectasis, pneumonia, and duration of hospital stay in adults undergoing cardiac and major abdominal surgery. The potential for overestimation of treatment effect due to lack of adequate blinding, small-study effects, and publication bias needs to be considered when interpreting the present findings.

Project description:IntroductionAnkle fractures have continued to occur through the COVID pandemic and, regardless of patient COVID status, often need operative intervention for optimizing long-term outcomes. For healthcare optimization, patient counseling, and care planning, understanding if COVID-positive patients undergoing ankle fracture surgery are at increased risk for perioperative adverse outcomes is of interest.MethodsThe COVID-19 Research Database contains recent United States aggregated insurance claims. Patients who underwent ankle fracture surgery from April 1st, 2020 to June 15th, 2020 were identified. COVID status was identified by ICD coding. Demographics, comorbidities, and postoperative complications were extracted based on administrative data. COVID-positive versus negative patients were compared with univariate analyses. Propensity-score matching was done on the basis of age, sex, and comorbidities. Multivariate regression was then performed to identify risk factors independently associated with the occurrence of 30-day postoperative adverse events.ResultsIn total, 9,835 patients undergoing ankle fracture surgery were identified, of which 57 (0.58%) were COVID-positive. COVID-positive ankle fracture patients demonstrated a higher prevalence of comorbidities, including: chronic kidney disease, diabetes, hypertension, and obesity (p<0.05 for each). After propensity matching and controlling for all preoperative variables, multivariate analysis found that COVID-positive patients were at increased risk of any adverse event (odds ratio [OR] = 3.89, p = 0.002), a serious adverse event (OR = 5.48, p = 0.002), and a minor adverse event (OR = 3.10, p = 0.021).DiscussionCOVID-positive patients will continue to present with ankle fractures requiring operative intervention. Even after propensity matching and controlling for patient factors, COVID-positive patients were found to be at increased risk of 30-day perioperative adverse events. Not only do treatment teams need to be protected from the transmission of COVID in such situations, but the increased incidence of perioperative adverse events needs to be considered.

Dataset Information

Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

Publications

Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure