Upper Extremity Elevation and Lungfunction After Open Heart Surgery

Sponsor

Michael Reinhart (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05278819

Collaborator

Region Örebro County (Other), Linkoeping University (Other), Örebro University, Sweden (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases Heart Diseases, Ischemic Heart Disease, Valvular	Other: upper extremity elevation Other: upper extremity elevation with deep breathing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

Effects of Upper Extremity Elevation and Deep Breathing on Oxygen Saturation and Lung Volume Two to Four Days After Open Heart Surgery

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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).	Other: upper extremity elevation 5 repetitions of active upper extremity elevation in a sitting position Other: upper extremity elevation with deep breathing 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).	Other: upper extremity elevation 5 repetitions of active upper extremity elevation in a sitting position Other: upper extremity elevation with deep breathing 5 repetitions of active upper extremity elevation with deep breathing in a sitting position

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).

Other: upper extremity elevation

5 repetitions of active upper extremity elevation in a sitting position

Other: upper extremity elevation with deep breathing

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).

Other: upper extremity elevation

5 repetitions of active upper extremity elevation in a sitting position

Other: upper extremity elevation with deep breathing

5 repetitions of active upper extremity elevation with deep breathing in a sitting position

Outcome Measures

Primary Outcome Measures

peripheral oxygen saturation [30 minutes]

Secondary Outcome Measures

tidal volume [30 minutes]
heart rate [30 minutes]
respiratory rate [30 minutes]
pain - numeric rating scale [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)
dyspnea - numeric rating scale [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)
exertion - numeric rating scale [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 %)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Michael Reinhart
Region Örebro County
Linkoeping University
Örebro University, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Reinhart, Physical therapist, Region Örebro County

ClinicalTrials.gov Identifier:

NCT05278819

Other Study ID Numbers:

278090

First Posted:

Mar 14, 2022

Last Update Posted:

Mar 14, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Heart Diseases

Myocardial Ischemia

Heart Valve Diseases

Study Results

No Results Posted as of Mar 14, 2022