Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00554580
First received: November 6, 2007
Last updated: March 29, 2010
Last verified: March 2010

November 6, 2007
March 29, 2010
October 2004
July 2008   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00554580 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Continuous Positive Airway Pressure for Acute Pulmonary Edema
Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Edema
  • Dyspnea
  • Paroxysmal
  • Congestive Heart Failure
  • 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.

    Other Name: Continuous Positive Airway Pressure (CPAP)
  • 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.

    Other Name: usual care of acute pulmonary oedema
  • Active Comparator: A
    Usual care of pulmonary acute oedema
    Intervention: Procedure: usual care of acute pulmonary oedema
  • Experimental: B
    CPAP + usual care of pulmonary acute oedema
    Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)
Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartière JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. doi: 10.1007/s00134-011-2311-4. Epub 2011 Jul 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00554580
P 030428, AOM 03073
Yes
Myriem TOUHAMI-CARRIER, Department clinical research of the developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: DUCROS Laurent, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP