The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439075
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.

Condition or disease Intervention/treatment Phase
Acute Cardiogenic Pulmonary Edema Procedure: CPAP Drug: standard treatment Phase 4

Detailed Description:

Acute cardiogenic pulmonary edema is a frequent medical emergency. Several studies have shown that continuous positive airway pressure is effective in acute cardiogenic pulmonary edema, through improvement in gas exchange, reduction in intubation rate and a trend towards reduced mortality. CPAP is usually obtained with a hermetic nasal or facemask witch has an expiratory valve to maintain a positive pressure at the end of the expiration. With this support, the patient does not receive any assistance with respiration.

The available data about CPAP concern patients hospitalised in cardiology intensive care units, in resuscitation areas or in emergency departments.

We will undertake a controlled prospective randomised trial to investigate whether the early use of CPAP would improve oxygenation and survival, as compared with standard medical therapy in patients with acute cardiogenic pulmonary edema.

This study will include 124 patients over 18 years of age, suffering of acute cardiogenic pulmonary edema, with a respiratory rate greater than 25 bpm and oxygen saturation less than 90 %. The patients will be include just after the beginning of the episode, in prehospital mobile intensive car unit (SAMU) and will be all admitted in resuscitation area in a central hospital. They will be randomly assigned to CPAP or conventional oxygen therapy. The randomisation sequence is generated by the random numbers table. Closed envelopes containing the allocated treatment will be stored in the emergency department and will be opened when the patient is included.

Oxygen saturation (by pulse-oxymetry), heart rate, respiratory rate, dyspnea, blood pressure will be measured every 15 min during the transport to the intensive care unit and every hour. The blood gazes will be measured at the arrival. The intubation rate, the duration of the hospitalisation and the mortality in the thirty days following initial treatment will be noted.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomised Controlled Comparison of Continuous Positive Airway Pressure (CPAP) With Standard Treatment in Out-of-hospital Patients With Acute Cardiogenic Pulmonary Edema.
Actual Study Start Date : October 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CPAP
positive airway pressure
Procedure: CPAP
Active Comparator: standard medical therapy
conventional oxygen therapy
Drug: standard treatment

Primary Outcome Measures :
  1. Treatment success after the one hour study period, defined as all of respiratory rate less than 25 bpm, oxygen saturation greater than 90 %. [ Time Frame: One hour ]

Secondary Outcome Measures :
  1. Physiological parameters: vital signs, dyspnea , intubation rate [ Time Frame: one hour ]
  2. Safety parameters: adverse events , duration of hospitalisation , mortality 5 days and 30 days after the end of the one hour study period. [ Time Frame: during hospitalisation ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient with supposed acute cardiogenic pulmonary edema, defined as acute dyspnea associated with a past of cardiomyopathy ischemia and physical signs consistent with pulmonary edema.
  • patient giving written informed consent

Exclusion Criteria:

  • Glasgow score < 10
  • Acute myocardial infarction ; ventricular arrhythmia ; pneumothorax ; evidence of pneumonia ; immediate need for intubation ; heart failure or respiratory stop witch requires a reanimation ; cardiogenic shock (systolic blood pressure < 90 mmhg)
  • Any neurological impairment that would prevent the protocol compliance
  • participation in another study throughout this one
  • women pregnant or nursing
  • vomiting
  • patient with an history of gastric surgery (< 8days)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439075

SAMU - University Hospital Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: DUCASSE Jean-Louis CHU Toulouse

Publications of Results:
Other Publications:

Responsible Party: University Hospital, Toulouse Identifier: NCT00439075     History of Changes
Other Study ID Numbers: 0508703
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by University Hospital, Toulouse:
pulmonary disease
out-of-hospital intervention

Additional relevant MeSH terms:
Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases