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

Centre Chirurgical Marie Lannelongue

Status: Unknown

Conditions: Reperfusion Pulmonary Edema

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02548091

2015-A00399-40

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Preventive non invasive ventilation

Active Comparator group

Description:

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).

Treatment:

Procedure: Non invasive ventilation

Procedure: Computed tomography (CT)

Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco)

Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)

Non invasive ventilation on demand

Other group

Description:

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.

Treatment:

Procedure: Non invasive ventilation

Procedure: Computed tomography (CT)

Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco)

Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)