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Upper Extremity Elevation and Lungfunction After Open Heart Surgery

Primary Purpose

Heart Diseases, Heart Diseases, Ischemic, Heart Disease, Valvular

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
upper extremity elevation
upper extremity elevation with deep breathing
Sponsored by
Michael Reinhart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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 %)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    upper extremity elevation

    upper extremity elevation with deep breathing

    Arm Description

    performing intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity 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).

    Outcomes

    Primary Outcome Measures

    peripheral oxygen saturation

    Secondary Outcome Measures

    tidal volume
    heart rate
    respiratory rate
    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)
    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)
    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)

    Full Information

    First Posted
    February 21, 2022
    Last Updated
    March 3, 2022
    Sponsor
    Michael Reinhart
    Collaborators
    Region Örebro County, Linkoeping University, Örebro University, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05278819
    Brief Title
    Upper Extremity Elevation and Lungfunction After Open Heart Surgery
    Official Title
    Effects of Upper Extremity Elevation and Deep Breathing on Oxygen Saturation and Lung Volume Two to Four Days After Open Heart Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Michael Reinhart
    Collaborators
    Region Örebro County, Linkoeping University, Örebro University, Sweden

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Diseases, Heart Diseases, Ischemic, Heart Disease, Valvular

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    upper extremity elevation
    Arm Type
    Experimental
    Arm Description
    performing intervention A (5 repetitions of upper extremity elevation), and then crossed over to intervention B (5 repetitions of upper extremity with deep breathing).
    Arm Title
    upper extremity elevation with deep breathing
    Arm Type
    Experimental
    Arm Description
    performing intervention B (5 repetitions of upper extremity with deep breathing), and then crossed over to intervention A (5 repetitions of upper extremity elevation).
    Intervention Type
    Other
    Intervention Name(s)
    upper extremity elevation
    Intervention Description
    5 repetitions of active upper extremity elevation in a sitting position
    Intervention Type
    Other
    Intervention Name(s)
    upper extremity elevation with deep breathing
    Intervention Description
    5 repetitions of active upper extremity elevation with deep breathing in a sitting position
    Primary Outcome Measure Information:
    Title
    peripheral oxygen saturation
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    tidal volume
    Time Frame
    30 minutes
    Title
    heart rate
    Time Frame
    30 minutes
    Title
    respiratory rate
    Time Frame
    30 minutes
    Title
    pain - numeric rating scale
    Description
    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)
    Time Frame
    30 minutes
    Title
    dyspnea - numeric rating scale
    Description
    Dyspnea will be measured before and after intervention, NRS will be used (patient rating of perceived dyspnea with a score from 0 to 10)
    Time Frame
    30 minutes
    Title
    exertion - numeric rating scale
    Description
    exertion will be measured before and after intervention, NRS will be used (patient rating of perceived exertion with a score from 0 to 10)
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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 %)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Reinhart
    Phone
    +46705370507
    Email
    michael.reinhart@regionorebrolan.se

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Upper Extremity Elevation and Lungfunction After Open Heart Surgery

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