- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502420
Lung Function After Abdominal Surgery
Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery
The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.
Inclusion: Patients undergoing surgery for abdominal surgery
Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.
Investigation: The day before surgery and the day after surgery
Primary outcome measures:
- Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.
- PaO2, PaCO2 and oxygen saturation (blood gas)
Study Overview
Status
Intervention / Treatment
Detailed Description
Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. The cause of postoperative restrictive lung function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of 2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.
The study aims to investigate changes in lung function and diffusion capacity for carbon monoxide after open and minimally invasive abdominal surgery and whether such changes can explain hypoxia after surgery.
Design: Prospective cohort study
Inclusion: Patients undergoing surgery for abdominal surgery
Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.
Method: The day before surgery and the day after surgery: Lung function (Vital capacity and FEV1) using box and diffusion capacity measurements and blood gas measurement
Primary outcome measures:
- Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion capacity for carbon monoxide.
- PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery, previously known lung disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Umeå, Sweden
- Dept surgery,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (18 years old and older) scheduled for surgery in the abdomen at department of Surgery, Urology and Gynecologi, Umeå University hospital.
- Must be able to perform a lung function test
Exclusion Criteria:
• Dementia or severe cognitive impairment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Abdominal surgery
People who to be operated in the abdomen are investigated before and after surgery.
|
A diagnostic test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diffusion capacity for carbon monoxide (DLCO)
Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Change in DLCO
|
Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vital capacity (VC)
Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Change in VC
|
Change from baseline (the day before surgery) to postoperative day 1 or 2
|
|
Forced expiratory volume (FEV1)
Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Change in FEV1
|
Change from baseline (the day before surgery) to postoperative day 1 or 2
|
|
Arterial PO2
Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Change in arterial PO2
|
Change from baseline (the day before surgery) to postoperative day 1 or 2
|
|
Arterial PCO2
Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Change in arterial PCO2
|
Change from baseline (the day before surgery) to postoperative day 1 or 2
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karl A Franklin, Prof, Inst Surgical and periopertive sciences, Umeå university, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-223-31M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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