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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventive non invasive ventilation | Active Comparator | 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). |
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| Non invasive ventilation on demand | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Injury Score. | Daily during hospitalization in the PACU on day 1 to 7. |
| Measure | Description | Time Frame |
|---|---|---|
| Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10). | The concentration will be given in pg/mL | 2 years |
| Extravascular Lung Water (EVLW) measures. | EVLW is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO). The unit of EVLW is mL/Kg |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PATRASCU ALINA, MD | Contact | 01 40 94 25 97 | a.patrascu@ccml.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Chirurgical Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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|
| Non invasive ventilation | Procedure |
|
| monitoring system Pulse-Induced Contour Cardiac Output (Picco) | Procedure |
|
| Computed tomography (CT) | Procedure |
|
| 2 years |
| Computed tomography (CT) score | 2 years |
| Doppler pulsatility of the portal vein and its pulsatility ratio | 2 years |
| Pulmonary Vascular Index (PVI) measures | PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO | 2 years |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D016209 | Interleukin-8 |
| D016753 | Interleukin-10 |
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019743 | Chemokines, CXC |
| D018925 | Chemokines |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007378 | Interleukins |
| D011506 | Proteins |
| D002630 | Chemotactic Factors |
| D001685 | Biological Factors |
| D018836 | Inflammation Mediators |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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