LOWOX

Not yet recruiting

Conditions: Surgery under general anesthesia

Registration Number: 2024-513117-12-00

Lead Sponsor: Region Vaesterbotten, Umea University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 200

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/m2.

Participation or recent participation within 30 days in a clinical trial with an investigational medicinal product. Previous participation in this trial.

Pregnancy

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in diffusion capacity for carbon monoxide on day 2 and after 3 months compared to the day preceding surgery (=baseline).		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 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.		Change in PaO2 and PaCO2 on day 1 and after 3 months compared to baseline.
Surgical site infections within 30 days of surgery.		Surgical site infections within 30 days of surgery.
Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months		Postoperative recovery using the Postoperative Recovery Profile at discharge and after 3 months
Hospital length of stay.		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.		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.

Trial Locations

Locations (3): Region Norrbotten
🇸🇪
Lulea, Sweden
Region Vaesterbotten
🇸🇪
Umea, Sweden
Region Vaesternorrland
🇸🇪
Sundsvall, Sweden
Region Norrbotten
🇸🇪Lulea, Sweden
Tomi Myrberg
Site contact
0920284000
tomi.myrberg@umu.se