Goal-directed Low Oxygen During Anesthesia

NCT05263154 | Unknown

• 1 other identifier: 2021-02211
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

postoperative hypoxia; abdominal surgery; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean change in arterial oxygen partial pressure after surgery vs. before surgery

  Oxygen partial pressure

  3 days

Secondary Outcomes (9)

• Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery

  3 days

• Mean change in vital capacity after surgery vs. before surgery

  3 days

• Mean change in forced expiratory volume in one second after surgery vs. before surgery

  3 days

• Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery

  3 days

• Mean change in arterial oxygen partial pressure after surgery vs. before surgery

  3 months

Study Arms (2)

Goal directed low oxygen

EXPERIMENTAL

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

Other: Goal directed low oxygen

High oxygen

ACTIVE COMPARATOR

Oxygen given as traditionally including high concentrations

Other: High oxygen

Interventions

Goal directed low oxygen 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.

Goal directed low oxygen

High oxygen 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%

High oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

University hospital

Umeå, SE 901 85, Sweden

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

high-potential iron-sulfur protein oxygen oxidoreductase

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl A Franklin, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl A Franklin, MD, Prof

CONTACT

+46 907851256; karl.franklin@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor, Consultant surgeon

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: March 28, 2022
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)