Postoperative Hypoxia and Body Position

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Hypoxia; Abdominal Surgery
• Intervention / Treatment: Other: change in body position

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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl A Franklin, Prof; Phone Number: +46 90 7850000; Email: karl.franklin@umu.se

Study Locations

• Sweden
  • Vasterbotten
    • Umea, Vasterbotten, Sweden, 90185
      • Recruiting
      • Dept of Surgery, University hospital
      • Contact: Karl A Franklin, MD, prof; Phone Number: +46 90. 7851256; Email: karl.franklin@umu.se

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: From supine to prone to supine position; Prone position	Other: change in body position; changing from supine to prone position and the back to supine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in oxygen partial pressure in supine vs. prone position.	Oxygen partial pressure	Through study completion, an average of 1 year
Mean change in oxygen saturation pressure in supine vs. prone position.	Oxygen saturation	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in carbon dioxide partial pressure pressure in supine vs. prone position.	Carbon dioxide partial pressure	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: karl A Franklin, Prof, Dept of Surgery, University Hospital, Umeå, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Respiratory; Postoperative Complications; Hypoxia
• Other Study ID Numbers: 2021-04457

Drug and device information, study documents

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