Lung Function After Abdominal Surgery

Postoperative Complications Clinical Trial

Official title:

Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04502420
• Other study ID #: 2018-223-31M
• Status: Completed
• Start date: August 17, 2020
• Est. completion date: October 17, 2021

Study information

• Verified date: January 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 17, 2021
• Est. primary completion date: October 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Surgery
• Lung Function
• Postoperative Complications

Intervention

Diagnostic Test:
• Lung function before and after surgery
A diagnostic test

Locations

Country	Name	City	State
Sweden	Dept surgery,	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion capacity for carbon monoxide (DLCO)	Change in DLCO	Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary	Vital capacity (VC)	Change in VC	Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary	Forced expiratory volume (FEV1)	Change in FEV1	Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary	Arterial PO2	Change in arterial PO2	Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary	Arterial PCO2	Change in arterial PCO2	Change from baseline (the day before surgery) to postoperative day 1 or 2