Continuous Positive Airway Pressure for Acute Pulmonary Edema

Phase 3

Completed

• Conditions: Pulmonary Edema; Dyspnea; Paroxysmal; Congestive Heart Failure
• Interventions: Procedure: usual care of acute pulmonary oedema; Procedure: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT00554580
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-29
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

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Exclusion Criteria

• age < 18
• immediate intubation criteria (bradypnea, coma status)
• refractory shock

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	usual care of acute pulmonary oedema	Usual care of pulmonary acute oedema
B	Continuous Positive Airway Pressure (CPAP)	CPAP + usual care of pulmonary acute oedema

Primary Outcome Measures

Name	Time	Method
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.	48 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

DUCROS Laurent; 🇫🇷 Paris, France