Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)
|Pulmonary Edema Dyspnea Paroxysmal Congestive Heart Failure||Procedure: Continuous Positive Airway Pressure (CPAP) Procedure: usual care of acute pulmonary oedema||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema|
- Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2. [ Time Frame: 48 hours ]
- brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol [ Time Frame: H0, H6, H24, H48 ]
|Study Start Date:||October 2004|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A
Usual care of pulmonary acute oedema
Procedure: usual care of acute pulmonary oedema
Usual treatment of acute pulmonary oedema including :
Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg.
Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes.
As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min.
CPAP + usual care of pulmonary acute oedema
Procedure: Continuous Positive Airway Pressure (CPAP)
Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy:
stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554580
|Paris, France, 75010|
|Principal Investigator:||DUCROS Laurent, MD PhD||Assistance Publique - Hôpitaux de Paris|