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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05278819
Other study ID # 278090
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date June 6, 2022

Study information

Verified date November 2023
Source Region Örebro County
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 6, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Sweden University Hospital Örebro

Sponsors (4)

Lead Sponsor Collaborator
Michael Reinhart Linkoeping University, Örebro University, Sweden, Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary peripheral oxygen saturation 30 minutes
Secondary tidal volume 30 minutes
Secondary heart rate 30 minutes
Secondary respiratory rate 30 minutes
Secondary pain - numeric rating scale 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
Secondary dyspnea - numeric rating scale 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
Secondary exertion - numeric rating scale 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
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