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CompletedNCT00405314Updated Jun 23, 2016

Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

An interventional study of Continuous positive airway pressure ventilation mask in Respiratory Insufficiency and Hypoxia, sponsored by Dalhousie University. Completed at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2016-06-23.

Sponsored by Dalhousie University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Respiratory Insufficiency
  • Hypoxia

Keywords

  • respiratory failure
  • non invasive ventilation
  • prehospital
  • endotracheal intubation
  • continuous positive airway pressure
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 60 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Dalhousie University is the lead sponsor of 50 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants

Interventions

  • DeviceContinuous positive airway pressure ventilation mask
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What researchers measure

Primary outcomes

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

Secondary outcomes

  1. mortality

  2. critical care unit length of stay

  3. hospital length of stay

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Study locations

1 site
  • Dalhousie University
    Halifax, Nova Scotia B3H 1V7, Canada
08

References and documents

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. PubMed 16713780 ↗
  • 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. PubMed 16646987 ↗
  • 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. PubMed 16997770 ↗
  • 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. PubMed 18387700 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00405314
Lead sponsor
Dalhousie University
Collaborators
Nova Scotia Health Authority
First posted
Nov 30, 2006
Start date
Jul 2002
Completion
Mar 2006
Last update
Jun 23, 2016

Study contacts

James Thompson, MD
principal investigator · University of British Columbia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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