PaO2 and Lung Function After Orthopedic Surgery

Sponsor
Umeå University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05227573
Collaborator
(none)
60
1
11.7
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Oxygen Partial Pressure and Lung Function After Orthopedic Surgery
Actual Study Start Date :
Feb 9, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Oxygen partial pressure [1 day]

    Change in oxygen partial pressure after surgery

Secondary Outcome Measures

  1. Vital capacity [1 day]

    Change in vital capacity after surgery

  2. Oxygen partial pressure [1 month]

    Change in oxygen partial pressure after surgery

  3. Carbon dioxide partial pressure [1 day]

    Change in carbon dioxide partial pressure after surgery

  4. Carbon dioxide partial pressure [1 month]

    Change in carbon dioxide partial pressure after surgery

  5. Vital capacity [1 month]

    Change in vital capacity after surgery

  6. Forced expiratory volume in one second [1 day]

    Change in Forced expiratory volume in one second after surgery

  7. Forced expiratory volume in one second [1 month]

    Change in Forced expiratory volume in one second after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept of Surgery, University hospital Umeå Vasterbotten Sweden 90185

Sponsors and Collaborators

  • Umeå University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karl A Franklin, Profesor, Consultant surgeon, Umeå University
ClinicalTrials.gov Identifier:
NCT05227573
Other Study ID Numbers:
  • 233
First Posted:
Feb 7, 2022
Last Update Posted:
Feb 28, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2022