OUT-OF-HOSPITAL CPAP STUDY

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00439075
First received: February 22, 2007
Last updated: July 25, 2007
Last verified: July 2007
  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 4

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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

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

Secondary Outcome Measures:
  • Physiological parameters: vital signs, dyspnea , intubation rate
  • Safety parameters: adverse events , duration of hospitalisation , mortality 5 days and 30 days after the end of the one hour study period.

Enrollment: 124
Study Start Date: October 2006
Study Completion Date: April 2007
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.

  Eligibility

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439075

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Pulmonary Edema
Lung Diseases
Respiratory Tract Diseases
Isosorbide-5-mononitrate
Isosorbide Dinitrate
Isosorbide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014