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Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

Primary Purpose

Respiratory Insufficiency, Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Continuous positive airway pressure ventilation mask
Sponsored by
Dalhousie University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring respiratory failure, non invasive ventilation, prehospital, endotracheal intubation, continuous positive airway pressure

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dalhousie University

Outcomes

Primary Outcome Measures

proportion of patients in each group endotracheally intubated prior to hospital discharge or death

Secondary Outcome Measures

mortality
critical care unit length of stay
hospital length of stay

Full Information

First Posted
November 29, 2006
Last Updated
June 22, 2016
Sponsor
Dalhousie University
Collaborators
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT00405314
Brief Title
Prehospital CPAP vs. Usual Care for Acute Respiratory Failure
Official Title
Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dalhousie University
Collaborators
Nova Scotia Health Authority

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency, Hypoxia
Keywords
respiratory failure, non invasive ventilation, prehospital, endotracheal intubation, continuous positive airway pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure ventilation mask
Primary Outcome Measure Information:
Title
proportion of patients in each group endotracheally intubated prior to hospital discharge or death
Secondary Outcome Measure Information:
Title
mortality
Title
critical care unit length of stay
Title
hospital length of stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Thompson, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16713780
Citation
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.
Results Reference
background
PubMed Identifier
16646987
Citation
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.
Results Reference
background
PubMed Identifier
16997770
Citation
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.
Results Reference
background
PubMed Identifier
18387700
Citation
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.
Results Reference
derived

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Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

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