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Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, December 2007
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00554580
  Purpose

We hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improve 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 Intervention Phase
Pulmonary Edema
Dyspnea
Paroxysmal
Congestive Heart Failure
Procedure: Continuous Positive Airway Pressure (CPAP)
Procedure: usual care of acute pulmonary oedema
Phase III

MedlinePlus related topics: Breathing Problems Edema Heart Failure
Drug Information available for: Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate Isosorbide Isosorbide dinitrate Isosorbide-5-mononitrate Furosemide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: October 2004
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
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 5 à 20 µg/kg/min.

B: Experimental
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • age < 18
  • immediate intubation criteria (bradypnea, coma status)
  • refractory shock
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554580

Contacts
Contact: DUCROS Laurent, MD Phd +33(1) 49 95 61 61 laurent.ducros@lrb.aphp.fr

Locations
France
DUCROS Laurent Recruiting
Paris, France, 75010
Contact: DUCROS Laurent, MD PhD            
Hôpital Lariboisière - Cardiologie Recruiting
Paris, France, 75010
Contact: HENRY Patrick, Pr     33-1 49.95.82.24        
Principal Investigator: HENRY Patrick, Pr            
Hopital Pitié Salpétrière-DAR-SMUR Recruiting
Paris, France, 75013
Contact: ECOLLAN Patrick, Pr     33-1 42 16 22 53        
Hopital Beaujon-DAR-SMUR Recruiting
Clichy, France, 92110
Contact: BELPOMME Vanessa, Pr     33-1 40 87 59 13        
Hopital Beaujon-Cardiologie Recruiting
Clichy, France, 92110
Contact: LOGEART Damien, Dr     33-1 40 8758 92        
Hopital Necker-SAMU75-SMUR Recruiting
Paris, France, 75015
Contact: JANNIERE Daniel, Pr     33-1 44 49 24 73        
Hopital Europeen Georges Pompidou-Cardiologie Recruiting
Paris, France, 75015
Contact: BENSOUDA Christophe, Pr     33-1 56 09 28 51        
Chu- Samu 29 Recruiting
Brest, France, 29200
Contact: VERGNE Muriel, Dr     33-2 98 34 79 00        
CHU Brest- UHCD Recruiting
Brest, France, 29200
Contact: L'HER Erwan, Pr     33-2 98 34 71 81        
CHU Brest-Cardiologie Recruiting
Brest, France, 29200
Contact: BLANC Jean Jaques, Pr     33-2 98 34 71 86        
Hopital Foch- Cardiologie Recruiting
Suresnes, France, 92
Contact: HAZIZA Franck, Dr     33-1 46 25 24 68        
CHR6Cardiologie Recruiting
Orleans La Source, France, 45100
Contact: DIBON Olivier     33-2 38 51 48 04        
Clinique de la Reine Blanche-Cardiologie Recruiting
Orleans, France, 45100
Contact: PLACENTE Marius, Dr     33-2 38 79 83 83        
CH Delafontaine-SMUR Recruiting
Saint Denis, France, 93
Contact: HENNEQUIN Brigitte     33-1 42 35 61 40        
CH Delafontaune-Réanimation médicale Recruiting
Saint Denis, France, 93
Contact: ADRIE Christophe     33-1 42 35 61 40 Bip 046        
Hopital Simone Veil-SMUR Recruiting
Eaubonne, France, 95600
Contact: EL SAYED KAMEL Mohamed, Pr     33-6 63 54 73 54        
CH-SMUR Recruiting
Montfermeil, France, 93370
Contact: CAVAGNA Patrick, Dr     33-1 41 70 80 00        
CH-Cardiologie Recruiting
Montfermeil, France, 93370
Contact: NALLET Olivier, Dr     33-1 41 70 81 01        
Contact: MICHAUD Pierre, Dr     33-1 41 70 81 01        
CH-Urgences-SMUR Recruiting
Beziers, France, 34543
Contact: FREDERIQUE Charles, Dr     33-4 67 35 70 96        
Hopital Simone Veil-Cardiologie Recruiting
Eaubonne, France, 95600
Contact: GHANEM Nachwan, Dr     33-1 34 06 60 00 Bip 7278        
CHR-SAMU 45 Recruiting
Orleans La Source, France, 45100
Contact: LAGARDE Sophie, Dr     33-2 38 66 85 26        
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: DUCROS Laurent, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: delegation clinical research of the developpement ( Myriem TOUHAMI-CARRIER )
Study ID Numbers: P 030428, AOM 03073
Study First Received: November 6, 2007
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00554580  
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Isosorbide
Heart Failure
Heart Diseases
Isosorbide-5-mononitrate
Edema
Isosorbide Dinitrate
Furosemide
Dobutamine
Signs and Symptoms
Pulmonary Edema
Respiratory Tract Diseases
Lung Diseases
Dyspnea

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009