Upper Extremity Elevation and Lungfunction After Open Heart Surgery

Not Applicable

Completed

• Conditions: Heart Diseases, Ischemic; Heart Diseases; Heart Disease, Valvular
• Interventions: Other: upper extremity elevation; Other: upper extremity elevation with deep breathing

• Registration Number: NCT05278819
• Lead Sponsor: Michael Reinhart

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.

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 Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-04-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
upper extremity elevation	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).
upper extremity elevation	upper extremity elevation with deep breathing	performing intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity with deep breathing).
upper extremity elevation with deep breathing	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).
upper extremity elevation with deep breathing	upper extremity elevation	performing intervention B (5 repetitions of upper extremity with deep breathing), and then crossed over to intervention A (5 repetitions of upper extremity elevation).

Primary Outcome Measures

Name	Time	Method
peripheral oxygen saturation	30 minutes

Secondary Outcome Measures

Name	Time	Method
heart rate	30 minutes
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)
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)
tidal volume	30 minutes
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)

Trial Locations

Locations (1)

University Hospital; 🇸🇪 Örebro, Sweden