Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

Not Applicable

Completed

• Conditions: Respiratory Insufficiency; Hypoxia

• Registration Number: NCT00405314
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-07
• Study Completion: 2006-03
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-22
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hospital length of stay
mortality
critical care unit length of stay

Trial Locations

Locations (1)

Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada