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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertensio

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 Summary:
Sponsor: Centre Chirurgical Marie Lannelongue

Current Primary Outcome: Lung Injury Score. [ Time Frame: Daily during hospitalization in the PACU on day 1 to 7. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centre Chirurgical Marie Lannelongue

Dates:
Date Received: September 3, 2015
Date Started: February 1, 2016
Date Completion: March 2018
Last Updated: February 24, 2017
Last Verified: February 2017