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Goal-directed Low Oxygen During Anesthesia

Primary Purpose

Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Goal directed low oxygen
High oxygen
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring postoperative hypoxia, abdominal surgery, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal directed low oxygen

High oxygen

Arm Description

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

Oxygen given as traditionally including high concentrations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Diffusion capacity
Mean change in vital capacity after surgery vs. before surgery
Vital capacity
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Forced expiratory volume in one second
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Carbon-dioxide partial pressure
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Oxygen partial pressure
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Diffusion capacity
Mean change in vital capacity after surgery vs. before surgery
Vital capacity
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Forced expiratory volume in one second
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Carbon-dioxide partial pressure

Full Information

First Posted
February 20, 2022
Last Updated
August 15, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT05263154
Brief Title
Goal-directed Low Oxygen During Anesthesia
Official Title
Goal-directed Low vs. High Oxygen Therapy During Anesthesia for Abdominal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
postoperative hypoxia, abdominal surgery, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal directed low oxygen
Arm Type
Experimental
Arm Description
Oxygen given at low concentrations following goals of oxygen saturation during and after anesthesia
Arm Title
High oxygen
Arm Type
Active Comparator
Arm Description
Oxygen given as traditionally including high concentrations
Intervention Type
Other
Intervention Name(s)
Goal directed low oxygen
Intervention Description
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
Intervention Name(s)
High oxygen
Intervention Description
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%
Primary Outcome Measure Information:
Title
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Description
Oxygen partial pressure
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Description
Diffusion capacity
Time Frame
3 days
Title
Mean change in vital capacity after surgery vs. before surgery
Description
Vital capacity
Time Frame
3 days
Title
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Description
Forced expiratory volume in one second
Time Frame
3 days
Title
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Description
Carbon-dioxide partial pressure
Time Frame
3 days
Title
Mean change in arterial oxygen partial pressure after surgery vs. before surgery
Description
Oxygen partial pressure
Time Frame
3 months
Title
Mean change in diffusion capacity for carbon-monoxide after surgery vs. before surgery
Description
Diffusion capacity
Time Frame
3 months
Title
Mean change in vital capacity after surgery vs. before surgery
Description
Vital capacity
Time Frame
3 months
Title
Mean change in forced expiratory volume in one second after surgery vs. before surgery
Description
Forced expiratory volume in one second
Time Frame
3 months
Title
Mean change in arterial carbon-dioxide partial pressure after surgery vs. before surgery
Description
Carbon-dioxide partial pressure
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl A Franklin, MD, Prof
Phone
+46 907851256
Email
karl.franklin@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, MD, PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital
City
Umeå
ZIP/Postal Code
SE 901 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, MD, Prof
Phone
+46907851256
Email
karl.franklin@umu.se
First Name & Middle Initial & Last Name & Degree
Magnus Hultin, MD, Ass Prof
Phone
460703505335
Email
Magnus.hultin@umu.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Depends on what is allowed according to Swedish Ethical authority.

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Goal-directed Low Oxygen During Anesthesia

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