Goal-directed Low Oxygen During Anesthesia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: Goal directed low oxygen; Other: High oxygen

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl A Franklin, MD, Prof; Phone Number: +46 907851256; Email: karl.franklin@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, SE 901 85
    • Recruiting
    • University Hospital
    • Contact: Karl A Franklin, MD, Prof; Phone Number: +46907851256; Email: karl.franklin@umu.se
    • Contact: Magnus Hultin, MD, Ass Prof; Phone Number: 460703505335; Email: Magnus.hultin@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal directed low oxygen; Oxygen given at low concentrations following goals of oxygen saturation during and after anesthesia	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.
Active Comparator: High oxygen; Oxygen given as traditionally including high concentrations	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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in arterial oxygen partial pressure after surgery vs. before surgery	Oxygen partial pressure	3 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Karl A Franklin, MD, PhD, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; abdominal surgery; postoperative hypoxia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2021-02211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Depends on what is allowed according to Swedish Ethical authority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No