Lung FunctionNCT04502420
Lung Function After Abdominal Surgery
An observational study of Lung Function and Postoperative Complications, run by Umeå University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Function, Postoperative Complications, Abdominal Surgery
- What is being tested?
- Lung function before and after surgery
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 17 Aug 2020to 17 Oct 2021
- Phase
- Observational
- 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
Study population: patients of 18 years old or olderundergoing abdominal surgery at department of Surgery, Urology and Gynecologi Umeå University hospital
Who may be able to join
- 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
Who cannot join
- Dementia or severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Being tested
- Lung function before and after surgery
- Keywords
- Lung function, Diffusion capacity, Postoperative complications, Abdominal surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung function before and after surgeryDiagnostic test
Also called Diffusion capacity and arterial blood gas before and after surgery.
A diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery | People who to be operated in the abdomen are investigated before and after surgery. Receives: Diagnostic Test: Lung function before and after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion capacity for carbon monoxide (DLCO)
Change in DLCO
Measured: Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary outcomes (4)
Vital capacity (VC)
Change in VC
Measured: Change from baseline (the day before surgery) to postoperative day 1 or 2
Forced expiratory volume (FEV1)
Change in FEV1
Measured: Change from baseline (the day before surgery) to postoperative day 1 or 2
Arterial PO2
Change in arterial PO2
Measured: Change from baseline (the day before surgery) to postoperative day 1 or 2
Arterial PCO2
Change in arterial PCO2
Measured: Change from baseline (the day before surgery) to postoperative day 1 or 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start17 Aug 2020
- Primary completion17 Oct 2021
- Study completion17 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Karl A Franklin, Umeå University
- Investigators
- Karl A Franklin, Prof, Principal investigator, Inst Surgical and periopertive sciences, Umeå university, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502420
- Sponsor's protocol ID
- 2018-223-31M
- Status last verified
- Jan 2023
- First submitted
- 28 Jul 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to share IPD if possible according to Swedish legislation
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04502420
- Acronym / sponsor ID
- 2018-223-31M
- Keywords
- Lung function, Diffusion capacity, Postoperative complications, Abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 17 Oct 2021 (actual)
- First posted
- 6 Aug 2020 (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 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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery | – | Diagnostic Test: Lung function before and after surgeryPeople who to be operated in the abdomen are investigated before and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of 18 years old or olderundergoing abdominal surgery at department of Surgery, Urology and Gynecologi Umeå University hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Dementia or severe cognitive impairment
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 |
|---|---|---|
| Lung function before and after surgeryAlso: Diffusion capacity and arterial blood gas before and after surgery.A diagnostic test | Diagnostic test | Abdominal surgery |
Primary outcome
Diffusion capacity for carbon monoxide (DLCO)
Time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
Change in DLCO
4 secondary outcomes
Vital capacity (VC)
Time frame: 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
Arterial PO2
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No. We plan to share IPD if possible according to Swedish legislation
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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
Inst Surgical and periopertive sciences, Umeå university, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Function and Postoperative Complications, 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 1 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: finished, as of the sponsor's last update on 25 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion capacity for carbon monoxide (DLCO) (time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2). 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 25 Jan 2023.