Prehospital CPAP vs. Usual Care for Acute Respiratory Failure
June 22, 2016 updated by: Dalhousie University
Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
60
Phase
- Not Applicable
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
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Dalhousie University
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-
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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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proportion of patients in each group endotracheally intubated prior to hospital discharge or death
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Secondary Outcome Measures
Outcome Measure |
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mortality
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hospital length of stay
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critical care unit length of stay
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Thompson, MD, University of British Columbia
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
- Wang HE, Yealy DM. Out-of-hospital endotracheal intubation: where are we? Ann Emerg Med. 2006 Jun;47(6):532-41. doi: 10.1016/j.annemergmed.2006.01.016. Epub 2006 Feb 28.
- Winck JC, Azevedo LF, Costa-Pereira A, Antonelli M, Wyatt JC. Efficacy and safety of non-invasive ventilation in the treatment of acute cardiogenic pulmonary edema--a systematic review and meta-analysis. Crit Care. 2006;10(2):R69. doi: 10.1186/cc4905.
- Hubble MW, Richards ME, Jarvis R, Millikan T, Young D. Effectiveness of prehospital continuous positive airway pressure in the management of acute pulmonary edema. Prehosp Emerg Care. 2006 Oct-Dec;10(4):430-9. doi: 10.1080/10903120600884848.
- Thompson J, Petrie DA, Ackroyd-Stolarz S, Bardua DJ. Out-of-hospital continuous positive airway pressure ventilation versus usual care in acute respiratory failure: a randomized controlled trial. Ann Emerg Med. 2008 Sep;52(3):232-41, 241.e1. doi: 10.1016/j.annemergmed.2008.01.006. Epub 2008 Apr 3.
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
July 1, 2002
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 29, 2006
First Posted (Estimate)
November 30, 2006
Study Record Updates
Last Update Posted (Estimate)
June 23, 2016
Last Update Submitted That Met QC Criteria
June 22, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAL06-04
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