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Clinical Trials/NCT04502420
NCT04502420
Completed
Not Applicable

Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery

Umeå University1 site in 1 country59 target enrollmentAugust 17, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Function
Sponsor
Umeå University
Enrollment
59
Locations
1
Primary Endpoint
Diffusion capacity for carbon monoxide (DLCO)
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 17, 2020
End Date
October 17, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karl A Franklin

Professor

Umeå University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diffusion capacity for carbon monoxide (DLCO)

Time Frame: Change from baseline (the day before surgery) to postoperative day 1 or 2

Change in DLCO

Secondary Outcomes

  • Arterial PO2(Change from baseline (the day before surgery) to postoperative day 1 or 2)
  • Vital capacity (VC)(Change from baseline (the day before surgery) to postoperative day 1 or 2)
  • Arterial PCO2(Change from baseline (the day before surgery) to postoperative day 1 or 2)
  • Forced expiratory volume (FEV1)(Change from baseline (the day before surgery) to postoperative day 1 or 2)

Study Sites (1)

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