Clinical trial NCT00405314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Hypoxia
Keywords: respiratory failure
non invasive ventilation
prehospital
endotracheal intubation
continuous positive airway pressure
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2006-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: proportion of patients in each group endotracheally intubated prior to hospital discharge or death
Secondary outcomes:
measure: mortality
measure: critical care unit length of stay
measure: hospital length of stay
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
Study officials:
affiliation: University of British Columbia
name: James Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.