Postoperative Hypoxia and Body Position

Postoperative Complications Clinical Trial

Official title:

Postoperative Hypoxia and Body Position

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246605
• Other study ID #: 2021-04457
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Umeå University
• Contact: Karl A Franklin, Prof
• Phone: +46 90 7850000
• Email: karl.franklin[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Surgery
• Hypoxia
• Postoperative Complications

Intervention

Other:
• change in body position
changing from supine to prone position and the back to supine

Locations

Country	Name	City	State
Sweden	Dept of Surgery, University hospital	Umea	Vasterbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in oxygen partial pressure in supine vs. prone position.	Oxygen partial pressure	Through study completion, an average of 1 year
Primary	Mean change in oxygen saturation pressure in supine vs. prone position.	Oxygen saturation	Through study completion, an average of 1 year
Secondary	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