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Clinical Trials/NCT02548091
NCT02548091
Unknown
N/A

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

Centre Chirurgical Marie Lannelongue1 site in 1 country236 target enrollmentFebruary 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Reperfusion Pulmonary Edema
Sponsor
Centre Chirurgical Marie Lannelongue
Enrollment
236
Locations
1
Primary Endpoint
Lung Injury Score.
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2016
End Date
March 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Lung Injury Score.

Time Frame: Daily during hospitalization in the PACU on day 1 to 7.

Secondary Outcomes

  • Doppler pulsatility of the portal vein and its pulsatility ratio(2 years)
  • Computed tomography (CT) score(2 years)
  • Pulmonary Vascular Index (PVI) measures(2 years)
  • Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).(2 years)
  • Extravascular Lung Water (EVLW) measures.(2 years)

Study Sites (1)

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