Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

NCT ID: NCT00405314

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2006-03-31

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.

Conditions

Respiratory Insufficiency; Hypoxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Continuous positive airway pressure ventilation mask

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: collaborator

Dalhousie University

OTHER

Sponsor Role: lead

Principal Investigators

James Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Dalhousie University

Halifax, Nova Scotia, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 16713780 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16646987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16997770 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18387700 (View on PubMed)

Other Identifiers

DAL06-04

Identifier Type: -

Identifier Source: org_study_id