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Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

NCT02548091 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2017-10-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.

Conditions

  • Reperfusion Pulmonary Edema

Interventions

OTHER

Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)

The same amount of blood sample is collected from both arms of study at the same time of the procedure. In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line.

PROCEDURE

Non invasive ventilation

PROCEDURE

monitoring system Pulse-Induced Contour Cardiac Output (Picco)

PROCEDURE

Computed tomography (CT)

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2017-11-30
Completion
2018-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548091 on ClinicalTrials.gov