Clinical trial NCT02548091: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
Official title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reperfusion Pulmonary Edema
Keywords: non invasive ventilation
reperfusion pulmonary edema
chronic thrombolic pulmonary hypertension
pulmonary artery angioplasty
Lead sponsor: Centre Chirurgical Marie Lannelongue
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years
* First and /or second procedure of pulmonary artery angioplasty
* Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
* Patient who signed informed consent
* Patients affiliated to a social security program

Exclusion criteria:

* severe neurological disease: Coma Glasgow Scale \< 8, severe cognitive decline, postural instability, loss of autonomy.
* psychiatric disease (illness)
* sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
* severe respiratory failure defined by a total lung capacity (TLC)\< 50% of the predicted value and/or expiratory volume in 1 second (FEV) \< 30% of predicted value
* obstructive sleep apnea syndrome with Continuous Positive Airway treatment
* preexisting hemorrhagic syndrome or coagulation factors deficiency
* severe renal insufficiency with glomerular filtration rate \< 30 ml/min
* severe hepatic failure with hepatic encephalopathy, hemodynamic disorder, decompensates cirrhosis, metabolic disorder( metabolic acidosis, hypoglycemia) hepatorenal syndrome, coagulation disorder (factor V\< 50%,disseminated intravascular coagulation)
* patient refusal of participation in the study program
* subjects not affiliated to social security program

Primary outcomes:
measure: Lung Injury Score.
timeFrame: Daily during hospitalization in the PACU on day 1 to 7.
Secondary outcomes:
measure: Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10).
timeFrame: 2 years
measure: Extravascular Lung Water (EVLW) measures.
timeFrame: 2 years
measure: Computed tomography (CT) score
timeFrame: 2 years
measure: Doppler pulsatility of the portal vein and its pulsatility ratio
timeFrame: 2 years
measure: Pulmonary Vascular Index (PVI) measures
timeFrame: 2 years
Other outcomes:
Locations:
city: Le Plessis Robinson
country: France
facility: Centre Chirurgical Marie Lannelongue
Study officials:
References: