Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405314
• Other study ID #: DAL06-04
• Status: Completed
• Phase: N/A
• First received: November 29, 2006
• Last updated: June 22, 2016
• Start date: July 2002
• Est. completion date: March 2006

Study information

• Verified date: June 2016
• Source: Dalhousie University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoxia
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• Continuous positive airway pressure ventilation mask

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Dalhousie University	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients in each group endotracheally intubated prior to hospital discharge or death
Secondary	mortality
Secondary	critical care unit length of stay
Secondary	hospital length of stay