NCT02548091

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Centre Chirurgical Marie Lannelongue · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2018-03-01
• First posted: 2015-09-14
• Last updated: 2017-10-13

Locations

1 site across 1 country: France