Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease

December 22, 2016 updated by: University of Split, School of Medicine
The aim of the study is to determine if increased retrograde shear would further deteriorate the already impaired vascular function in severe COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: control subjects-retrograde flow
Retrograde flow was induced in control subjects.
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.
No Intervention: control subjects-control
Experimental: hypoxemic COPD-retrograde flow
Retrograde flow was induced in hypoxemic COPD patients.
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.
No Intervention: hypoxemic COPD-control
Experimental: normoxemic COPD-retrograde flow with oxygen
Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation.
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.
Other: oxygen
Supplemental 100% oxygen administered through a nasal cannula.
Experimental: normoxemic COPD-control with oxygen
COPD patients with normalized arterial oxygen saturation.
Other: oxygen
Supplemental 100% oxygen administered through a nasal cannula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes
Time Frame: 0,10, 20 and 25 minutes
0,10, 20 and 25 minutes
Change from Baseline Microparticle Count at 20 minutes
Time Frame: 0 and 20 minutes
0 and 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Split, School of Medicine

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

April 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on retrograde flow

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe