PeRioperative OXygen fraction – effect on surgical site Infection and pulmonary complications after abdominal surgery. (The PROXI-study) - The PROXI-study
- Conditions
- aparotomy
- Registration Number
- EUCTR2006-001710-32-DK
- Lead Sponsor
- Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1400
Inclusion Criteria
Age 18 years or older.
Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypic or neoplastic cells).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Surgery within 30 days before scheduled laparotomy (except surgery in local anaesthesia)
Chemotherapy within 3 months
Inability to give informed consent
Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulseoximetry)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on surgical site infection and pulmonary complications after abdominal surgery.<br><br>Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical site infection after abdominal surgery <br>;Secondary Objective: To investigate the effect of perioperative oxygen fraction (FiO2 30% vs. 80%) on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of stay in hospital and intensive care unit after abdominal surgery.;Primary end point(s): Surgical site infection
- Secondary Outcome Measures
Name Time Method