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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retrograde flow
oxygen
Sponsored by
University of Split, School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    No Intervention

    Experimental

    No Intervention

    Experimental

    Experimental

    Arm Label

    control subjects-retrograde flow

    control subjects-control

    hypoxemic COPD-retrograde flow

    hypoxemic COPD-control

    normoxemic COPD-retrograde flow with oxygen

    normoxemic COPD-control with oxygen

    Arm Description

    Retrograde flow was induced in control subjects.

    Retrograde flow was induced in hypoxemic COPD patients.

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

    COPD patients with normalized arterial oxygen saturation.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2016
    Last Updated
    December 22, 2016
    Sponsor
    University of Split, School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03004352
    Brief Title
    Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease
    Official Title
    Disturbed Blood Flow Induces Endothelial Dysfunction in Severe Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Split, School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control subjects-retrograde flow
    Arm Type
    Experimental
    Arm Description
    Retrograde flow was induced in control subjects.
    Arm Title
    control subjects-control
    Arm Type
    No Intervention
    Arm Title
    hypoxemic COPD-retrograde flow
    Arm Type
    Experimental
    Arm Description
    Retrograde flow was induced in hypoxemic COPD patients.
    Arm Title
    hypoxemic COPD-control
    Arm Type
    No Intervention
    Arm Title
    normoxemic COPD-retrograde flow with oxygen
    Arm Type
    Experimental
    Arm Description
    Retrograde flow was induced in COPD patients with normalized arterial oxygen saturation.
    Arm Title
    normoxemic COPD-control with oxygen
    Arm Type
    Experimental
    Arm Description
    COPD patients with normalized arterial oxygen saturation.
    Intervention Type
    Other
    Intervention Name(s)
    retrograde flow
    Intervention Description
    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
    Intervention Name(s)
    oxygen
    Intervention Description
    Supplemental 100% oxygen administered through a nasal cannula.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Brachial Artery Diameter at 10, 20 and 25 minutes
    Time Frame
    0,10, 20 and 25 minutes
    Title
    Change from Baseline Microparticle Count at 20 minutes
    Time Frame
    0 and 20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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