| November 6, 2007 |
| December 20, 2007 |
| 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 ] |
| |
| Continuous Positive Airway Pressure for Acute Pulmonary Edema |
| 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. |
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. |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
- Pulmonary Edema
- Dyspnea
- Paroxysmal
- Congestive Heart Failure
|
- Procedure: Continuous Positive Airway Pressure (CPAP)
- Procedure: usual care of acute pulmonary oedema
|
- Active Comparator: Usual care of pulmonary acute oedema
- Experimental: CPAP + usual care of pulmonary acute oedema
|
| |
| |
| Recruiting |
| 400 |
| March 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 sus 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 |
|
|
| France |
| |
| NCT00554580 |
| Myriem TOUHAMI-CARRIER, delegation clinical research of the developpement |
| P 030428, AOM 03073 |
| Assistance Publique - Hôpitaux de Paris |
|
| Principal Investigator: |
DUCROS Laurent, MD PhD |
Assistance Publique - Hôpitaux de Paris |
|
|
| Assistance Publique - Hôpitaux de Paris |
| December 2007 |
