Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)
|ClinicalTrials.gov Identifier: NCT00554580|
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : March 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Edema Dyspnea Paroxysmal Congestive Heart Failure||Procedure: Continuous Positive Airway Pressure (CPAP) Procedure: usual care of acute pulmonary oedema||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554580
|Paris, France, 75010|
|Principal Investigator:||DUCROS Laurent, MD PhD||Assistance Publique - Hôpitaux de Paris|