Goal-directed Low Oxygen During Anesthesia

Umeå University

Status: Enrolling

Conditions: Postoperative Complications

Treatments: Other: Goal directed low oxygen; Other: High oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05263154

2021-02211

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Goal directed low oxygen

Experimental group

Description:

Oxygen given at low concentrations following goals of oxygen saturation during and after anesthesia

Treatment:

Other: Goal directed low oxygen

High oxygen

Active Comparator group

Description:

Oxygen given as traditionally including high concentrations

Treatment:

Other: High oxygen