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

Not Applicable

• Conditions: Reperfusion Pulmonary Edema
• Interventions: Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10); Procedure: Non invasive ventilation; Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco); Procedure: Computed tomography (CT)

• Registration Number: NCT02548091
• Lead Sponsor: Centre Chirurgical Marie Lannelongue

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2016-02-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13
• Primary Completion: 2017-11
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preventive non invasive ventilation	Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)	Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
Non invasive ventilation on demand	Computed tomography (CT)	Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
Non invasive ventilation on demand	Non invasive ventilation	Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
Non invasive ventilation on demand	Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)	Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
Non invasive ventilation on demand	monitoring system Pulse-Induced Contour Cardiac Output (Picco)	Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
Preventive non invasive ventilation	Non invasive ventilation	Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
Preventive non invasive ventilation	Computed tomography (CT)	Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
Preventive non invasive ventilation	monitoring system Pulse-Induced Contour Cardiac Output (Picco)	Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).

Primary Outcome Measures

Name	Time	Method
Lung Injury Score.	Daily during hospitalization in the PACU on day 1 to 7.

Secondary Outcome Measures

Name	Time	Method
Computed tomography (CT) score	2 years
Pulmonary Vascular Index (PVI) measures	2 years	PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO
Doppler pulsatility of the portal vein and its pulsatility ratio	2 years
Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).	2 years	The concentration will be given in pg/mL
Extravascular Lung Water (EVLW) measures.	2 years	EVLW is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO). The unit of EVLW is mL/Kg

Trial Locations

Locations (1)

Centre Chirurgical Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France