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Completed

NCT Number: NCT04502420

Lung Function 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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept surgery,

Umeå, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung function before and after surgery

Diagnostic Test

A diagnostic test

Other names: Diffusion capacity and arterial blood gas before and after surgery.

Primary outcomes

  1. 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

  1. Vital capacity (VC)

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

    Change in VC

  2. Forced expiratory volume (FEV1)

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

    Change in FEV1

  3. Arterial PO2

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

    Change in arterial PO2

  4. Arterial PCO2

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

    Change in arterial PCO2

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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