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Postoperative Hypoxia and Body Position

Primary Purpose

Postoperative Complications, Abdominal Surgery, Hypoxia

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
change in body position
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications

Eligibility Criteria

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

Inclusion Criteria:

  • Being operated within 2 in the abdomen because of upper gastrointestinal surgery, colorectal surgery, urological surgery or emergency surgery
  • Must be able to turn from supine position to prone position in the bed

Exclusion Criteria:

  • Esophageal surgery, Abdominal vessel surgery.
  • Decline participation.

Sites / Locations

  • Dept of Surgery, University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

From supine to prone to supine position

Arm Description

Prone position

Outcomes

Primary Outcome Measures

Mean change in oxygen partial pressure in supine vs. prone position.
Oxygen partial pressure
Mean change in oxygen saturation pressure in supine vs. prone position.
Oxygen saturation

Secondary Outcome Measures

Mean change in carbon dioxide partial pressure pressure in supine vs. prone position.
Carbon dioxide partial pressure

Full Information

First Posted
January 26, 2022
Last Updated
March 28, 2023
Sponsor
Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT05246605
Brief Title
Postoperative Hypoxia and Body Position
Official Title
Postoperative Hypoxia and Body Position
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (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 the oxygen partial pressure is improved in the prone position postoperative after abdominal surgery. Included are 50 adults operated with abdominal surgery. The Intervention is turning from supine to prone position and then back to supine position while measuring whether an improvement occurs in oxygen saturation and oxygen partial pressure, or not.
Detailed Description
Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that oxygen partial pressure decreases by an average of 2 kPa after abdominal surgery, while carbon dioxide partial pressure is unchanged and vital capacity decreases by 35%. Patients are operated and treated in the post anesthesia care unit in the supine position. The study aims at investigate whether the oxygen partial pressure is improved in the prone position postoperative after abdominal surgery or not. Inclusion: 50 adults operated with abdominal surgery. Exclusion: Esophageal surgery, Abdominal vessel surgery. Decline participation. Intervention: turning from supine to prone position and then back to supine position again. Primary outcome: Change in oxygen saturation and oxygen partial pressure. Secondary outcome: Change in carbondioxide partial pressure Procedures: Partial blood gas is taken before surgery. On the day of surgery or the day after: starting in supine position with continuous measurements of oxygen saturation from pulse oximetry, transcutaneous carbon-dioxide partial pressure and blood gas. Then turning to prone position and then back to supine position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Abdominal Surgery, Hypoxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
From supine to prone to supine position
Arm Type
Experimental
Arm Description
Prone position
Intervention Type
Other
Intervention Name(s)
change in body position
Intervention Description
changing from supine to prone position and the back to supine
Primary Outcome Measure Information:
Title
Mean change in oxygen partial pressure in supine vs. prone position.
Description
Oxygen partial pressure
Time Frame
Through study completion, an average of 1 year
Title
Mean change in oxygen saturation pressure in supine vs. prone position.
Description
Oxygen saturation
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Mean change in carbon dioxide partial pressure pressure in supine vs. prone position.
Description
Carbon dioxide partial pressure
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being operated within 2 in the abdomen because of upper gastrointestinal surgery, colorectal surgery, urological surgery or emergency surgery Must be able to turn from supine position to prone position in the bed Exclusion Criteria: Esophageal surgery, Abdominal vessel surgery. Decline participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl A Franklin, Prof
Phone
+46 90 7850000
Email
karl.franklin@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
karl A Franklin, Prof
Organizational Affiliation
Dept of Surgery, University Hospital, Umeå, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Surgery, University hospital
City
Umea
State/Province
Vasterbotten
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl A Franklin, MD, prof
Phone
+46 90. 7851256
Email
karl.franklin@umu.se

12. IPD Sharing Statement

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Postoperative Hypoxia and Body Position

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