Clinical trial NCT04502420: Lung Function After Abdominal Surgery
Official title: Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Function
Postoperative Complications
Abdominal Surgery
Keywords: Lung function
Diffusion capacity
Postoperative complications
Abdominal surgery
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2020-08-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Diffusion capacity for carbon monoxide (DLCO)
timeFrame: Change from baseline (the day before surgery) to postoperative day 1 or 2
Secondary outcomes:
measure: Vital capacity (VC)
timeFrame: Change from baseline (the day before surgery) to postoperative day 1 or 2
measure: Forced expiratory volume (FEV1)
timeFrame: Change from baseline (the day before surgery) to postoperative day 1 or 2
measure: Arterial PO2
timeFrame: Change from baseline (the day before surgery) to postoperative day 1 or 2
measure: Arterial PCO2
timeFrame: Change from baseline (the day before surgery) to postoperative day 1 or 2
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept surgery,
Study officials:
affiliation: Inst Surgical and periopertive sciences, Umeå university, Sweden
name: Karl A Franklin, Prof
role: PRINCIPAL_INVESTIGATOR
References: