Continuous Positive Airway Pressure for Acute Pulmonary Edema - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00554580

Purpose

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.

Condition	Intervention	Phase
Pulmonary Edema Dyspnea Paroxysmal Congestive Heart Failure	Procedure: Continuous Positive Airway Pressure (CPAP) Procedure: usual care of acute pulmonary oedema	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems Edema Heart Failure

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	208
Study Start Date:	October 2004
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Usual care of pulmonary acute oedema	Procedure: 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. Other Name: usual care of acute pulmonary oedema
Experimental: B CPAP + usual care of pulmonary acute oedema	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. Other Name: Continuous Positive Airway Pressure (CPAP)

Arms

Assigned Interventions

Active Comparator: A

Usual care of pulmonary acute oedema

Procedure: 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.

Other Name: usual care of acute pulmonary oedema

Experimental: B

CPAP + usual care of pulmonary acute oedema

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.

Other Name: Continuous Positive Airway Pressure (CPAP)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554580

Locations

France
DUCROS Laurent
Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

DUCROS Laurent, MD PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartière JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. Epub 2011 Jul 30.

Responsible Party:	Myriem TOUHAMI-CARRIER, Department clinical research of the developpement
ClinicalTrials.gov Identifier:	NCT00554580 History of Changes
Other Study ID Numbers:	P 030428, AOM 03073
Study First Received:	November 6, 2007
Last Updated:	March 29, 2010
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

continuous positive airway pressure
outcome measure
clinical trial

Additional relevant MeSH terms:

Dyspnea
Edema
Heart Failure
Pulmonary Edema
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Lung Diseases

ClinicalTrials.gov processed this record on February 09, 2012