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

NCT03004352 | Completed

• 1 other identifier: ED-COPD
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes

  0,10, 20 and 25 minutes

• Change from Baseline Microparticle Count at 20 minutes

  0 and 20 minutes

Study Arms (6)

control subjects-retrograde flow

EXPERIMENTAL

Retrograde flow was induced in control subjects.

Other: retrograde flow

control subjects-control

NO INTERVENTION

hypoxemic COPD-retrograde flow

EXPERIMENTAL

Retrograde flow was induced in hypoxemic COPD patients.

Other: retrograde flow

hypoxemic COPD-control

NO INTERVENTION

normoxemic COPD-retrograde flow with oxygen

EXPERIMENTAL

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

Other: retrograde flow; Other: oxygen

normoxemic COPD-control with oxygen

EXPERIMENTAL

COPD patients with normalized arterial oxygen saturation.

Other: oxygen

Interventions

retrograde flow 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-retrograde flow; hypoxemic COPD-retrograde flow; normoxemic COPD-retrograde flow with oxygen

oxygen OTHER

Supplemental 100% oxygen administered through a nasal cannula.

normoxemic COPD-control with oxygen; normoxemic COPD-retrograde flow with oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD
• chronic hypoxemia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 28, 2016
• Study Start: April 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share