Official Title: “Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2008

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.

Intervention(s) in this Clinical Trial

• 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.
• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Usual care of pulmonary acute oedema
• Experimental: B
  • CPAP + usual care of pulmonary acute oedema

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

DUCROS Laurent, MD PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00554580

Study ID Number: P 030428

ClinicalTrials.gov Identifier: NCT00554580

Health Authority: France: Ministry of Health