Postoperative ComplicationsNCT05246605
Postoperative Hypoxia and Body Position
A study testing change in body position in people with Postoperative Complications and Abdominal Surgery, run by Umeå University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Abdominal Surgery, Hypoxia
- What is being tested?
- change in body position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 16 Mar 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Esophageal surgery, Abdominal vessel surgery.
- Decline participation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept of Surgery, University hospital
Umeå, Västerbotten County, 90185
Karl A Franklin, MD, prof, +46 90. 7851256, karl.franklin@umu.se
About this study
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.
Read the 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.
- Conditions
- Postoperative Complications, Abdominal Surgery, Hypoxia
- Being tested
- change in body position
- Medical subject headings
- Postoperative Complications, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in body positionOther
changing from supine to prone position and the back to supine
| Study group | Role | What they receive |
|---|---|---|
| From supine to prone to supine position | Experimental | Prone position Receives: Other: change in body position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in oxygen partial pressure in supine vs. prone position.
Oxygen partial pressure
Measured: Through study completion, an average of 1 year
Mean change in oxygen saturation pressure in supine vs. prone position.
Oxygen saturation
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Mean change in carbon dioxide partial pressure pressure in supine vs. prone position.
Carbon dioxide partial pressure
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 Mar 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- karl A Franklin, Prof, Principal investigator, Dept of Surgery, University Hospital, Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246605
- Sponsor's protocol ID
- 2021-04457
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypoxia and Body Position
- ClinicalTrials.gov ID
- NCT05246605
- Acronym / sponsor ID
- 2021-04457
- Conditions
- Postoperative Complications, Abdominal Surgery, Hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| From supine to prone to supine position | Experimental | Other: change in body positionProne position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Esophageal surgery, Abdominal vessel surgery.
- Decline participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change in body positionchanging from supine to prone position and the back to supine | Other | From supine to prone to supine position |
Primary outcome
Mean change in oxygen partial pressure in supine vs. prone position.
Time frame: Through study completion, an average of 1 year
Oxygen partial pressure
Mean change in oxygen saturation pressure in supine vs. prone position.
Time frame: Through study completion, an average of 1 year
Oxygen saturation
1 secondary outcome
Mean change in carbon dioxide partial pressure pressure in supine vs. prone position.
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
karl A Franklin, Prof principal investigator
Dept of Surgery, University Hospital, Umeå, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change in body position in people with Postoperative Complications and Abdominal Surgery, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl A Franklin, Prof (+46 90 7850000, karl.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in oxygen partial pressure in supine vs. prone position. (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.