2024-513117-12-00
Not yet recruiting
Phase III and phase IV (Integrated)
Goal-directed low oxygen concentration during anesthesia compared to fixed oxygen concentration: A single blind, phase IV, randomized controlled multicenter trial
Region Vaesterbotten, Umea University3 sites in 1 country200 target enrollmentStarted: October 29, 2024Last updated:
Overview
- Phase
- Phase III and phase IV (Integrated)
- Status
- Not yet recruiting
- Sponsor
- Region Vaesterbotten, Umea University
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
Overview
Brief Summary
To investigate if there is an improvement in postoperative arterial oxygen partial pressure (PaO2) after goal-directed low oxygen concentration during anesthesia compared to the routine use with fixed oxygen concentrations.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (> 18 years old)
- •The subject has given their written consent to participate in the trial.
- •Be scheduled for abdominal surgery performed at the Departments of Surgery, Urology and Gynecology lasting more than 2 hours.
- •Fall under the American Society of Anesthesia (ASA) Class 1-3.
Exclusion Criteria
- •Increased risk for difficult intubation during anesthesia (Mallampati score 3-4) or previous documentation of difficult intubation.
- •The inability to understand written or verbal information, thereby hindering the ability to provide informed consent.
- •Obese with a BMI >35 kg/m
- •Participation or recent participation within 30 days in a clinical trial with an investigational medicinal product. Previous participation in this trial.
Outcomes
Primary Outcomes
Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
Arterial oxygen partial pressure (PaO2) measured on postoperative day 2 compared to the day before surgery. Supplemental oxygen will be ceased before the blood sampling, if possible, for 30 minutes or longer.
Secondary Outcomes
- Change in diffusion capacity for carbon monoxide on day 2 and after 3 months compared to the day preceding surgery (=baseline).
- Change in vital capacity (VC) on day 2 and after 3 months compared to baseline.
- Change in PaO2 and PaCO2 on day 1 and after 3 months compared to baseline.
- Surgical site infections within 30 days of surgery.
- Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months
- Hospital length of stay.
- Effect of background variables on outcomes, including age, sex, height, weight, body mass index (BMI), type of surgery, duration of surgery, and type of anesthesia.
Investigators
Karl Franklin
Scientific
Region Vaesterbotten
Study Sites (3)
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