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| Sponsor: | University Hospital, Toulouse |
|---|---|
| Information provided by: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00439075 |
Purpose
Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Cardiogenic Pulmonary Edema |
Drug: Standard treatment: isosorbide dinitrate Drug: furosemide |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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. |
| Enrollment: | 124 |
| Study Start Date: | October 2006 |
| Study Completion Date: | April 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00439075 History of Changes |
| Other Study ID Numbers: | 0508703 |
| Study First Received: | February 22, 2007 |
| Last Updated: | July 25, 2007 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
pulmonary disease CPO CPAP oxygenation out-of-hospital intervention |
|
Edema Pulmonary Edema Signs and Symptoms Lung Diseases Respiratory Tract Diseases Furosemide Isosorbide Isosorbide-5-mononitrate Isosorbide Dinitrate Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Diuretics Natriuretic Agents Physiological Effects of Drugs Cardiovascular Agents Therapeutic Uses Vasodilator Agents Nitric Oxide Donors Diuretics, Osmotic |