Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00554580
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : March 30, 2010
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.

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

Detailed Description:
Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
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
Study Start Date : October 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.

Experimental: B
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age > 18
  • acute respiratory insufficiency with hypoxia in air
  • KILLIP score from 2 to 4
  • absence of known ST elevation acute coronary syndrome
  • accepted inform consent.

Exclusion Criteria:

  • age < 18
  • immediate intubation criteria (bradypnea, coma status)
  • refractory shock

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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 identifier (NCT number): NCT00554580

DUCROS Laurent
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: DUCROS Laurent, MD PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Myriem TOUHAMI-CARRIER, Department clinical research of the developpement Identifier: NCT00554580     History of Changes
Other Study ID Numbers: P 030428
AOM 03073
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
continuous positive airway pressure
outcome measure
clinical trial

Additional relevant MeSH terms:
Heart Failure
Pulmonary Edema
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases