Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

NCT00405314 | Completed

• 1 other identifier: DAL06-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency; Hypoxia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• proportion of patients in each group endotracheally intubated prior to hospital discharge or death

Secondary Outcomes (3)

• mortality

• critical care unit length of stay

• hospital length of stay

Interventions

Continuous positive airway pressure ventilation mask DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Dalhousie University

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Related Publications (4)

• 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.

  PMID: 16713780 BACKGROUND

• 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.

  PMID: 16646987 BACKGROUND

• 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.

  PMID: 16997770 BACKGROUND

• 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.

  PMID: 18387700 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Thompson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: July 1, 2002
• Study Completion: March 1, 2006
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

CA (1)