NCT00439075

OUT-OF-HOSPITAL CPAP STUDY

Randomised Controlled Comparison of Continuous Positive Airway Pressure (CPAP) With Standard Treatment in Out-of-hospital Patients With Acute Cardiogenic Pulmonary Edema.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Acute Cardiogenic Pulmonary Edema

Interventions

Type	Name	Description
PROCEDURE	CPAP
DRUG	standard treatment

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-02-23
• Last updated: 2017-05-12

Locations

1 site across 1 country: France