NCT05246605

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

March 16, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

January 26, 2022

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

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

    Through study completion, an average of 1 year

Study Arms (1)

From supine to prone to supine position

EXPERIMENTAL

Prone position

Other: change in body position

Interventions

changing from supine to prone position and the back to supine

From supine to prone to supine position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Surgery, University hospital

Umeå, Västerbotten County, 90185, Sweden

RECRUITING

MeSH Terms

Conditions

Postoperative ComplicationsHypoxia

Interventions

Posture

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • karl A Franklin, Prof

    Dept of Surgery, University Hospital, Umeå, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karl A Franklin, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor, Consultant surgeon

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 18, 2022

Study Start

March 16, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations