- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436030
Atrial and Ventricular Wall Stress During Breathing
April 19, 2019 updated by: Umeå University
Atrial and Ventricular Wall Stress, Effects of Breathing and Airway Pressure
Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip.
Ultrasound heart images captured before and during.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg raising, and handgrip.
Echocardiographic recordings are made before and during each intervention.
Participants are otherwise resting in a reclined position.
Study Type
Interventional
Enrollment (Actual)
40
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
-
-
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Umeå, Sweden, 90185
- Umeå University, and the University Hospital of Umeå
-
-
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 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy adults
Exclusion Criteria:
- known heart or lung disease
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: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single arm, breathing manuevers
All subjects perform/undergo Valsalva, Muller, CPAP, hand grip, and passive leg raise, with ultrasound examination of heart recorded before and during the manoeuvre.
|
Valsalva, Muller, light mask CPAP, leg raising, hand grip.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver
Time Frame: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence
|
Echocardiographic measure, comparing control measurement to measurement during breathing manoeuver
|
30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
November 18, 2017
Primary Completion (ACTUAL)
April 30, 2018
Study Completion (ACTUAL)
April 30, 2018
Study Registration Dates
First Submitted
December 15, 2017
First Submitted That Met QC Criteria
February 15, 2018
First Posted (ACTUAL)
February 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 19, 2019
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2017-327-31M
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.
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