Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
A
Usual care of pulmonary acute oedema
Intervention: usual care of acute pulmonary oedema (Procedure)
B
CPAP + usual care of pulmonary acute oedema
Intervention: Continuous Positive Airway Pressure (CPAP) (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- 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(H0, H6, H24, H48)