Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Dyspnea; Paroxysmal; Pulmonary Edema; Congestive Heart Failure

Treatments: Procedure: Continuous Positive Airway Pressure (CPAP); Procedure: usual care of acute pulmonary oedema

Study type: Interventional

Funder types: Other

Identifiers

NCT00554580

P 030428

AOM 03073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

A

Active Comparator group

Description:

Usual care of pulmonary acute oedema

Treatment:

Procedure: usual care of acute pulmonary oedema

B

Experimental group

Description:

CPAP + usual care of pulmonary acute oedema

Treatment:

Procedure: Continuous Positive Airway Pressure (CPAP)