Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
NCT ID: NCT02548091
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
236 participants
INTERVENTIONAL
2016-02-01
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Preventive non invasive ventilation
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).
Blood 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.
Non invasive ventilation
monitoring system Pulse-Induced Contour Cardiac Output (Picco)
Computed tomography (CT)
Non invasive ventilation on demand
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.
Blood 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.
Non invasive ventilation
monitoring system Pulse-Induced Contour Cardiac Output (Picco)
Computed tomography (CT)
Interventions
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Blood 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.
Non invasive ventilation
monitoring system Pulse-Induced Contour Cardiac Output (Picco)
Computed tomography (CT)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Chirurgical Marie Lannelongue
OTHER
Responsible Party
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Locations
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Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Countries
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Central Contacts
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Other Identifiers
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2015-A00399-40
Identifier Type: -
Identifier Source: org_study_id