PaO2 and Lung Function After Orthopedic Surgery

Oxygen Partial Pressure and Lung Function After Orthopedic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Orthopedic Disorder
• Intervention / Treatment: Procedure: Orthopedic surgery

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

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Sweden
  • Vasterbotten
    • Umeå, Vasterbotten, Sweden, 90185
      • Recruiting
      • Dept of Surgery, University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing shoulder or elbow surgery

Description

Inclusion Criteria: Patients undergoing shoulder or elbow surgery -

Exclusion Criteria: Dementia or cognitive impairment that makes it impossible to participate in studies. Not willing to participate

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen partial pressure	Change in oxygen partial pressure after surgery	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital capacity	Change in vital capacity after surgery	1 day
Oxygen partial pressure	Change in oxygen partial pressure after surgery	1 month
Carbon dioxide partial pressure	Change in carbon dioxide partial pressure after surgery	1 day
Carbon dioxide partial pressure	Change in carbon dioxide partial pressure after surgery	1 month
Vital capacity	Change in vital capacity after surgery	1 month
Forced expiratory volume in one second	Change in Forced expiratory volume in one second after surgery	1 day
Forced expiratory volume in one second	Change in Forced expiratory volume in one second after surgery	1 month

Collaborators and Investigators

• Sponsor: Umeå University
• Investigators: Principal Investigator: Karl A Franklin, Prof, Surgical and Perioperative Sciences, Surgery, Umeå University, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2022
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (ACTUAL): February 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Musculoskeletal Diseases
• Other Study ID Numbers: 233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No