Prehospital CPAP vs. Usual Care for Acute Respiratory Fai... | NCT00405314

Studies
Prehospital CPAP vs. Usual Care for Acute Respiratory Failure

NCT00405314

Sponsor

Dalhousie University

Status

Completed

Last Update Posted

Jun 23, 2016Estimated

Enrollment

Phase

Not Applicable

Conditions

Respiratory Insufficiency
Hypoxia

Interventions

Continuous positive airway pressure ventilation mask

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Nov 29, 2006

First Submission Date that Met QC Criteria

Nov 29, 2006

First Posted Date

Nov 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2016

Last Update Posted Date

Jun 23, 2016Estimated

Name	Class
Nova Scotia Health Authority	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Continuous positive airway pressure ventilation mask	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of patients in each group endotracheally intubated prior to hospital discharge or death

Secondary Outcomes

Measure	Description	Time Frame
mortality
critical care unit length of stay
hospital length of stay

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Thompson, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dalhousie University		Halifax	Nova Scotia	B3H 1V7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16713780	Background	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.
16646987	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.

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D012131	Respiratory Insufficiency
D000860	Hypoxia