Prehospital CPAP vs. Usual Care for Acute Respiratory Failure - Full Text View

Sponsor:	Dalhousie University
Collaborator:	Capital District Health Authority, Canada
Information provided by:	Dalhousie University
ClinicalTrials.gov Identifier:	NCT00405314

Purpose

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.

Condition	Intervention
Respiratory Insufficiency Hypoxia	Device: Continuous positive airway pressure ventilation mask

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prehospital CPAP Versus Usual Care for Acute Respiratory Failure: a Randomized Controlled Trial

Further study details as provided by Dalhousie University:

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

Estimated Enrollment:	60
Study Start Date:	July 2002
Estimated Study Completion Date:	March 2006

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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405314

Locations

Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 1V7

Sponsors and Collaborators

Dalhousie University

Capital District Health Authority, Canada

Investigators

Principal Investigator:

James Thompson, MD

University of British Columbia

More Information

Publications:

Wang HE, Yealy DM. Out-of-hospital endotracheal intubation: where are we? Ann Emerg Med. 2006 Jun;47(6):532-41. Epub 2006 Feb 28.

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Apr 3.

Study ID Numbers:	DAL06-04
Study First Received:	November 29, 2006
Last Updated:	November 29, 2006
ClinicalTrials.gov Identifier:	NCT00405314 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Dalhousie University:

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

Additional relevant MeSH terms:

Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Signs and Symptoms, Respiratory
Anoxia

ClinicalTrials.gov processed this record on February 08, 2010