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CompletedNCT03004352Updated Dec 28, 2016

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

An interventional study of retrograde flow and oxygen in Chronic Obstructive Pulmonary Disease, sponsored by University of Split, School of Medicine. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-28.

Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 27 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University of Split, School of Medicine is the lead sponsor of 49 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • COPD
  • chronic hypoxemia

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    control subjects-retrograde flow

    Retrograde flow was induced in control subjects.

    Other: retrograde flow

  • No intervention
    control subjects-control
  • Experimental
    hypoxemic COPD-retrograde flow

    Retrograde flow was induced in hypoxemic COPD patients.

    Other: retrograde flow

  • 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 · Other: oxygen

  • Experimental
    normoxemic COPD-control with oxygen

    COPD patients with normalized arterial oxygen saturation.

    Other: oxygen

Interventions

  • Otherretrograde 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.

  • Otheroxygen

    Supplemental 100% oxygen administered through a nasal cannula.

06

What researchers measure

Primary outcomes

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

    Time frame: 0,10, 20 and 25 minutes

  2. Change from Baseline Microparticle Count at 20 minutes

    Time frame: 0 and 20 minutes

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03004352
Lead sponsor
University of Split, School of Medicine
Responsible party
Sponsor
First posted
Dec 28, 2016
Start date
Apr 2015
Primary completion
May 2015
Completion
May 2015
Last update
Dec 28, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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