Viewing Study NCT04502420


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Study NCT ID: NCT04502420
Status: COMPLETED
Last Update Posted: 2023-01-25
First Post: 2020-07-28
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Lung Function After Abdominal Surgery
Sponsor: UmeƄ University
Organization:

Study Overview

Official Title: Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery
Status: COMPLETED
Status Verified Date: 2023-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: