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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03004352
Other study ID # ED-COPD
Secondary ID
Status Completed
Phase N/A
First received December 20, 2016
Last updated December 22, 2016
Start date April 2015
Est. completion date May 2015

Study information

Verified date December 2016
Source University of Split, School of Medicine
Contact n/a
Is FDA regulated No
Health authority Croatia: School CouncilCroatia: UNIST Ethics CommiteeCroatia: Agency for Science and Higher Education - Committee for Ethics in Science and Higher Education
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- COPD

- chronic hypoxemia

Exclusion Criteria:

- an acute exacerbation, active respiratory infection or infection of other localisation 6 weeks prior to the visit

- relevant coexisting lung disease such as interstitial lung disease, cancer, renal failure, thromboembolic disease or major cardiovascular event during the previous year

- informed consent not provided or inability to comply with the study protocol

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
retrograde flow
Two pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention.
oxygen
Supplemental 100% oxygen administered through a nasal cannula.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Split, School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes 0,10, 20 and 25 minutes No
Primary Change from Baseline Microparticle Count at 20 minutes 0 and 20 minutes No
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