Reperfusion Pulmonary Edema
Conditions
Keywords
non invasive ventilation, reperfusion pulmonary edema, chronic thrombolic pulmonary hypertension, pulmonary artery angioplasty
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.
Interventions
OTHERBlood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)
The same amount of blood sample is collected from both arms of study at the same time of the procedure. In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line.
PROCEDURENon invasive ventilation
PROCEDUREmonitoring system Pulse-Induced Contour Cardiac Output (Picco)
PROCEDUREComputed tomography (CT)
Sponsors
Centre Chirurgical Marie Lannelongue
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung Injury Score. | Daily during hospitalization in the PACU on day 1 to 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Computed tomography (CT) score | 2 years | — |
| Doppler pulsatility of the portal vein and its pulsatility ratio | 2 years | — |
| Pulmonary Vascular Index (PVI) measures | 2 years | PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO |
Countries
France
Contacts
Primary ContactPATRASCU ALINA, MD
Outcome results
None listed