Goal-directed Low Oxygen During Anesthesia

NCT ID: NCT05263154

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2025-03-31

Brief 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.

Detailed 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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Goal directed low oxygen

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

Group Type: EXPERIMENTAL

Goal directed low oxygen

Intervention Type: OTHER

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

Oxygen given as traditionally including high concentrations

Group Type: ACTIVE_COMPARATOR

High oxygen

Intervention Type: OTHER

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%

Interventions

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.

Intervention Type: OTHER

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%

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Karl A Franklin

Profesor, Consultant surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl A Franklin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

University hospital

Umeå, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Karl A Franklin, MD, Prof

Role: CONTACT

karl.franklin@umu.se

+46 907851256

Facility Contacts

Karl A Franklin, MD, Prof

Role: primary

karl.franklin@umu.se

+46907851256

Magnus Hultin, MD, Ass Prof

Role: backup

Magnus.hultin@umu.se

460703505335

Other Identifiers

2021-02211

Identifier Type: -

Identifier Source: org_study_id