Lung Function After Abdominal Surgery

January 21, 2023 updated by: Karl A Franklin, Umeå University

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

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

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Umeå, Sweden
        • Dept surgery,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients of 18 years old or olderundergoing abdominal surgery at department of Surgery, Urology and Gynecologi Umeå University hospital

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Diffusion capacity and arterial blood gas before and after surgery.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Karl A Franklin, Prof, Inst Surgical and periopertive sciences, Umeå university, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2020

Primary Completion (Actual)

October 17, 2021

Study Completion (Actual)

October 17, 2021

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 6, 2020

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

January 1, 2023

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)?

No

IPD Plan Description

We plan to share IPD if possible according to Swedish legislation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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