Continuous Positive Airway Pressure for Acute Pulmonary Edema

Congestive Heart Failure Clinical Trial

— CPAP  

Official title:

Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554580
• Other study ID #: P 030428
• Secondary ID: AOM 03073
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2007
• Last updated: March 29, 2010
• Start date: October 2004
• Est. completion date: July 2008

Study information

• Verified date: March 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Dyspnea
• Edema
• Heart Failure
• Paroxysmal
• Pulmonary Edema

Intervention

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.
• 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 to 5 to 20 µg/kg/min.

Locations

Country	Name	City	State
France	DUCROS Laurent	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes