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Completed

NCT Number: NCT00405314

Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

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.

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Key information

Conditions

Respiratory Insufficiency Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dalhousie University

Halifax, Nova Scotia, B3H 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous positive airway pressure ventilation mask

Device

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

Sponsors and collaborators

Lead sponsor

Dalhousie University

Other

Collaborators

  • Nova Scotia Health Authority

Registry information

Official study title

Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial

Important dates

Study start
2002
Study completion
2006
First posted
Nov 30, 2006
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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