Goal-directed Low Oxygen During Anesthesia

Postoperative Complications Clinical Trial

Official title:

Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263154
• Other study ID #: 2021-02211
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: August 2023
• Source: Umeå University
• Contact: Karl A Franklin, MD, Prof
• Phone: +46 907851256
• Email: karl.franklin[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims at investigate whether low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery. 200 patients scheduled for abdominal surgery will be randomized (1:1) to goal directed low oxygen concentration during and after anesthesia vs. fixed high oxygen concentration. Arterial oxygen partial pressure is the primary outcome and lung function a secondary explanatory outcome.

Description:

Postoperative hypoxia is a most common complication after major abdominal surgery. This study aims at investigate whether goal-directed low oxygen therapy during anesthesia improves oxygen partial pressure and lung function in the postoperative period after abdominal surgery.

200 adult patients scheduled for major abdominal cancer surgery lasting for more than 2 hours will be included after signed informed consent. Patients will then be randomized to either goal directed low oxygen or high oxygen during anesthesia and in the postoperative period.

Patients who are randomized to goal directed low oxygen will be given oxygen before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary, Patients who are randomized to high oxygen will be given FiO2 of 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%.

Arterial blood gases, lung function measurements including diffusion capacity will be taken on the day before surgery. Blood gases will be taken during the first and second day after surgery and lung function tests during the second day after surgery. Blood gases and lung function will also be obtained at three months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being scheduled for a major abdominal cancer surgery lasting for more than 2 hours.

• Having a condition within American Society of Anesthesia Class 1-3.

Exclusion Criteria:

• Being at risk for a difficult intubation during anesthesia in the form of Mallampati score 3-4, or having a previous documentation of difficult intubation.

• Decline participation

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Other:
• Goal directed low oxygen
Oxygen is titrated until oxygen saturation is 100% in one-minute steps before the induction of anesthesia, with increasing fraction of inspired oxygen (FiO2) from 0.25 to 0.30 to 0.35 and so on. After intubation, the FiO2 is set to 0.25 to achieve a target saturation of 94-96%. Supplementary oxygen after surgery will be given with the same targets and with as little oxygen as necessary.
• High oxygen
FiO2 1.0 before induction until end-tidal oxygen concentrations of 0.80 occur. The FiO2 will be reduced to 0.35 during anesthesia, followed by an increase in FiO2 to 0.80 during 5 minutes before extubating the patient, followed by FiO2 0.40 for at least thirty minutes after anesthesia. Oxgen will then be given at 3 liters a minute with a oxygen saturation goal of 98%

Locations

Country	Name	City	State
Sweden	University hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in arterial oxygen partial pressure after surgery vs. before surgery	Oxygen partial pressure	3 days
Secondary	Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery	Diffusion capacity	3 days
Secondary	Mean change in vital capacity after surgery vs. before surgery	Vital capacity	3 days
Secondary	Mean change in forced expiratory volume in one second after surgery vs. before surgery	Forced expiratory volume in one second	3 days
Secondary	Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery	Carbon-dioxide partial pressure	3 days
Secondary	Mean change in arterial oxygen partial pressure after surgery vs. before surgery	Oxygen partial pressure	3 months
Secondary	Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery	Diffusion capacity	3 months
Secondary	Mean change in vital capacity after surgery vs. before surgery	Vital capacity	3 months
Secondary	Mean change in forced expiratory volume in one second after surgery vs. before surgery	Forced expiratory volume in one second	3 months
Secondary	Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery	Carbon-dioxide partial pressure	3 months