Upper Extremity Elevation and Lungfunction After Open Heart Surgery
November 23, 2023 updated by: Michael Reinhart
Effects of Upper Extremity Elevation and Deep Breathing on Oxygen Saturation and Lung Volume Two to Four Days After Open Heart Surgery
The purpose of this study is to assess if arm elevation, with or without simultaneous deep breathing, affects oxygen saturation and lung function on patients two to four days after open heart surgery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This single center, interventional crossover study will involve patients day 2, 3 or 4 after open heart surgery.
Patients who meet the eligibility requirements will be informed about the study and potential risks, given a written informed consent they will be included for intervention being held later on the same day.
Randomization will be given to the investigator in a sealed envelope and being opened after base line measurements.
Data will then be collected for the randomized intervention and after a wash out period (several minutes) again for the crossover intervention.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Örebro, Sweden, 70186
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- open heart surgery at university hospital in Örebro
Exclusion Criteria:
- not able to communicate in swedish
- difficulties in cooperating during measurements
- cognitive impairement
- prolonged stay at ICU (still at ICU on the day of investigation)
- ongoing oxygen treatment with more than 5 liter/minut (FiO > 40 %)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: upper extremity elevation
performing intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity with deep breathing).
|
5 repetitions of active upper extremity elevation in a sitting position
5 repetitions of active upper extremity elevation with deep breathing in a sitting position
|
|
Experimental: upper extremity elevation with deep breathing
performing intervention B (5 repetitions of upper extremity with deep breathing), and then crossed over to intervention A (5 repetitions of upper extremity elevation).
|
5 repetitions of active upper extremity elevation in a sitting position
5 repetitions of active upper extremity elevation with deep breathing in a sitting position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
peripheral oxygen saturation
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tidal volume
Time Frame: 30 minutes
|
30 minutes
|
|
|
heart rate
Time Frame: 30 minutes
|
30 minutes
|
|
|
respiratory rate
Time Frame: 30 minutes
|
30 minutes
|
|
|
pain - numeric rating scale
Time Frame: 30 minutes
|
Pain (sternal, thorax or overall pain) will be measured before and after intervention, NRS will be used (patient rating of perceived pain with a score from 0 to 10)
|
30 minutes
|
|
dyspnea - numeric rating scale
Time Frame: 30 minutes
|
Dyspnea will be measured before and after intervention, NRS will be used (patient rating of perceived dyspnea with a score from 0 to 10)
|
30 minutes
|
|
exertion - numeric rating scale
Time Frame: 30 minutes
|
exertion will be measured before and after intervention, NRS will be used (patient rating of perceived exertion with a score from 0 to 10)
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
June 1, 2022
Study Completion (Actual)
June 6, 2022
Study Registration Dates
First Submitted
February 21, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 278090
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.