PaO2 and Lung Function After Orthopedic Surgery

NCT ID: NCT05227573

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2024-05-01

Brief Summary

Hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. This study aims to investigate whether similar changes also occur after orthopedic surgery in the form of upper limb surgery.

Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery.

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Arterial blood gas and lung function are undertaken before surgery, the day after surgery and at follow-up.

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 effect of orthopedic surgery on oxygen and carbon dioxide partial pressure and lung function has previously not been investigated. This study aims to investigate possible changes in oxygen partial pressure and vital capacity after orthopedic surgery.

Design: Prospective cohort study

Inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery..

Exclusion: Dementia or cognitive impairment that makes it impossible to participate in studies.

Method: Blood gas measurements and Lung function (Vital capacity and FEV1) The day before surgery, the day after surgery and at follow-up.

Power analysis: There is a need to investigate 34 patients if the mean (SD) difference is 1 (2) kPa. Due to drop-outs the investigators calculate a need to include 60 patients.

Primary outcome measures:

• PaO2 from atrial blood gas

Secondary outcomes

• Vital capacity
• PaCO2 from atrial blood gas
• Forced expiratory volume in one second (FEV1)

Other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery and previous diseases

Conditions

Postoperative Complications; Orthopedic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Orthopedic surgery

Knee-, hip-, shoulder- and elbow surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Karl A Franklin

Profesor, Consultant surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl A Franklin, Prof

Role: PRINCIPAL_INVESTIGATOR

Surgical and Perioperative Sciences, Surgery, Umeå University, Sweden

Locations

Dept of Surgery, University hospital

Umeå, Västerbotten County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Karl A Franklin, Prof

Role: CONTACT

karl.franklin@umu.se

+46 706884745

Facility Contacts

Karl A Franklin, MD, prof

Role: primary

karl.franklin@umu.se

+46 90 7851256

Other Identifiers

233

Identifier Type: -

Identifier Source: org_study_id