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CompletedNCT03436030Updated Apr 22, 2019

Atrial and Ventricular Wall Stress During Breathing

An interventional study of Simple breathing manuevers during brief echocardiographic imaging in Healthy, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by Umeå University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy adults

Exclusion criteria

Exclusion Criteria:

  • known heart or lung disease
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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.

    Other: Simple breathing manuevers during brief echocardiographic imaging

Interventions

  • OtherSimple breathing manuevers during brief echocardiographic imaging

    Valsalva, Muller, light mask CPAP, leg raising, hand grip.

05

What researchers measure

Primary outcomes

  1. Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver

    Echocardiographic measure, comparing control measurement to measurement during breathing manoeuver

    Time frame: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence

06

Study locations

1 site
  • Umeå University, and the University Hospital of Umeå
    Umeå, 90185, Sweden
07

References and documents

Publications

  • Gottfridsson P, A'Roch R, Lindqvist P, Law L, Myrberg T, Hultin M, A'Roch A, Haney M. Left atrial contraction strain and controlled preload alterations, a study in healthy individuals. Cardiovasc Ultrasound. 2022 Mar 30;20(1):8. doi: 10.1186/s12947-022-00278-1. Erratum In: Cardiovasc Ultrasound. 2022 Apr 26;20(1):12. doi: 10.1186/s12947-022-00281-6. PubMed 35354482 ↗
08

Registry details

Key details

Study ID
NCT03436030
Lead sponsor
Umeå University
Collaborators
Region Västerbotten
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Nov 18, 2017
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Last update
Apr 22, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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