Skip to content

Goal-directed low oxygen concentration during anesthesia compared to fixed oxygen concentration: A single blind, phase IV, randomized controlled multicenter trial

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513117-12-00
Enrollment
200
Registered
2024-10-29
Start date
2025-01-16
Completion date
Unknown
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery under general anesthesia

Brief summary

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.

Detailed description

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.

Interventions

DRUGOXYGEN

Sponsors

Region Vaesterbotten, Umea University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026