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

NCT ID: NCT03004352

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control subjects-retrograde flow

Retrograde flow was induced in control subjects.

Group Type EXPERIMENTAL

retrograde flow

Intervention Type OTHER

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.

control subjects-control

Group Type NO_INTERVENTION

No interventions assigned to this group

hypoxemic COPD-retrograde flow

Retrograde flow was induced in hypoxemic COPD patients.

Group Type EXPERIMENTAL

retrograde flow

Intervention Type OTHER

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.

hypoxemic COPD-control

Group Type NO_INTERVENTION

No interventions assigned to this group

normoxemic COPD-retrograde flow with oxygen

Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation.

Group Type EXPERIMENTAL

retrograde flow

Intervention Type OTHER

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

Intervention Type OTHER

Supplemental 100% oxygen administered through a nasal cannula.

normoxemic COPD-control with oxygen

COPD patients with normalized arterial oxygen saturation.

Group Type EXPERIMENTAL

oxygen

Intervention Type OTHER

Supplemental 100% oxygen administered through a nasal cannula.

Interventions

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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.

Intervention Type OTHER

oxygen

Supplemental 100% oxygen administered through a nasal cannula.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Split, School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ED-COPD

Identifier Type: -

Identifier Source: org_study_id