OUT-OF-HOSPITAL CPAP STUDY

May 10, 2017 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • SAMU - University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CPAP
positive airway pressure
Procedure: CPAP
ACTIVE_COMPARATOR: standard medical therapy
conventional oxygen therapy
Drug: standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One hour

Secondary Outcome Measures

Outcome Measure
Time Frame
Physiological parameters: vital signs, dyspnea , intubation rate
Time Frame: one hour
one hour
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
during hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: DUCASSE Jean-Louis, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2006

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (ESTIMATE)

February 23, 2007

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0508703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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