Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 35
- Primary Endpoint
- Change in PaO2/FiO2-index during general anaesthesia.
Study Overview
Brief Summary
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery.
Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration.
Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Laparatomy, elective
Exclusion Criteria
- •Inability to give informed consent
- •Chemotherapy within 3 months
- •Other surgery within 30 days(except surgery in local anaesthesia)
- •Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)
Arms & Interventions
1
Group 1 is given 30% oxygen during and 2 hours after surgery
Intervention: Oxygen (Drug)
2
Group 2 is given 80% during and 2 hours after surgery.
Intervention: Oxygen (Drug)
Outcomes
Primary Outcomes
Change in PaO2/FiO2-index during general anaesthesia.
Time Frame: End of surgery.
Secondary Outcomes
- Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery.(1½ hour after surgery.)
- Atelectasis and Pneumonia(14 days after surgery)
- Arterial oxygen saturation(2 hours and 3 days after surgery.)
- Change in functional residual capacity (FRC)(2 hours after surgery.)
- Change in effective pulmonary bloodflow(2 hours after surgery.)