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Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT00405314
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by:
Dalhousie University

Brief Summary:
The purpose of this study is to evaluate the effectiveness of continuous positive airway pressure ventilation when applied by paramedics to individuals with severe breathing difficulties in the prehospital setting.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Hypoxia Device: Continuous positive airway pressure ventilation mask Not Applicable

Detailed Description:
Continuous positive airway pressure ventilation (CPAP) has been shown to be effective in avoiding endotracheal intubation (ETI) for patients with acute respiratory failure in hospital but despite several case series, the effectiveness of the prehospital application of CPAP by paramedics has not been studied in a randomized fashion. We performed a prospective, randomized, non blinded trial to determine whether patients in acute respiratory failure treated with CPAP in the prehospital setting had lower overall ETI rates than those treated with standard care.

Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial
Study Start Date : July 2002
Study Completion Date : March 2006





Primary Outcome Measures :
  1. proportion of patients in each group endotracheally intubated prior to hospital discharge or death

Secondary Outcome Measures :
  1. mortality
  2. critical care unit length of stay
  3. hospital length of stay


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • severe dyspnea
  • respiratory rate >25 breaths/minute
  • hemodynamically stable
  • able to cooperate with ventilatory support measures
  • assessed by paramedics as being in urgent need of ETI and/or manual positive pressure ventilation
  • a trip destination of the QEII Health Sciences Center or Dartmouth General Hospital

Exclusion Criteria:

  • require ETI for immediate airway protection
  • respiratory rate < 8 breaths/minute
  • evidence of hemodynamic instability
  • cardiac ischemia
  • any chest pain within 3 hours of presentation
  • valid "do not resuscitate" advanced directive
  • an inadequate supply of portable oxygen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405314


Locations
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Dalhousie University
Nova Scotia Health Authority
Investigators
Principal Investigator: James Thompson, MD University of British Columbia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00405314     History of Changes
Other Study ID Numbers: DAL06-04
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Dalhousie University:
respiratory failure
non invasive ventilation
prehospital
endotracheal intubation
continuous positive airway pressure

Additional relevant MeSH terms:
Respiratory Insufficiency
Hypoxia
Respiratory Distress Syndrome, Adult
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases