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| Tracking Information | |||||
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| First Received Date ICMJE | February 22, 2007 | ||||
| Last Updated Date | July 25, 2007 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Treatment success after the one hour study period, defined as all of respiratory rate less than 25 bpm, oxygen saturation greater than 90 %. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00439075 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | OUT-OF-HOSPITAL CPAP STUDY | ||||
| Official Title ICMJE | Randomised Controlled Comparison of Continuous Positive Airway Pressure (CPAP) With Standard Treatment in Out-of-Hospital Patients With Acute Cardiogenic Pulmonary Edema. | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Acute Cardiogenic Pulmonary Edema | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 124 | ||||
| Completion Date | April 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00439075 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 0508703 | ||||
| Study Sponsor ICMJE | University Hospital, Toulouse | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Toulouse | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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