The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial - Full Text View

Purpose

Patients who are intubated (breathing tube in windpipe) are often transported by air ambulance. Changes in atmospheric pressure during flight may cause pressure increases in the air-filled cuff holding the tube in the windpipe. Studies show that more than half the patients had potentially harmful pressures in the cuff during flight. High pressures lead to complications, such as injury to the windpipe. To avoid injury, cuff pressures must be kept at a safe level. There are many ways to avoid unsafe cuff pressures. One is to inflate the cuff with sterile fluid instead of air. Fluids are not subject to changes in atmospheric pressure. Using fluid, instead of air, in the cuff causes less pressure increases and less windpipe injury. The use and safety profile of this during transport by air ambulance has not been studied. This study compares tracheal tube cuff pressures, filled with air or fluid, at routine flying altitudes during patient transports by air ambulance.

Condition	Intervention
Injury of Trachea Friction and Pressure Injuries Barotrauma Transfer/Transport Injury	Other: Saline in tube cuff

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Prevention
Official Title:	The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety (OCTOPUS) Trial

Further study details as provided by Ornge Transport Medicine:

Primary Outcome Measures:

The primary outcome measure is the incidence of tracheal tube cuff pressure exceeding 30 cm H2O during the cruise portion of flight. [ Time Frame: During cruise portion of flight, approximately 10-15 minutes after aircraft take-off. ] [ Designated as safety issue: Yes ]
The flight paramedics will measure the tracheal tube cuff pressure during the cruise portion of flight, approximately 10-15 minutes after the aircraft has taken off.

Secondary Outcome Measures:

Incidence of tracheal tube cuff pressure exceeding 30 cm H2O on initial inflation of the cuff prior to departure from sending facility. [ Time Frame: Prior to departure from sending facility ] [ Designated as safety issue: Yes ]
The flight paramedics will measure the tracheal tube cuff pressure prior to departing the sending facility.
The change in cuff pressure from ground to in flight at cruising altitude. [ Time Frame: During cruise portion of flight. ] [ Designated as safety issue: Yes ]
The flight paramedics will measure the tracheal tube cuff pressure during the cruise portion of flight, approximately 10-15 minutes after the aircraft has taken off.
The incidence of cuff leak or other tracheal tube malfunction. [ Time Frame: Any point during care ] [ Designated as safety issue: Yes ]
The flight paramedics will identify if there has been a tracheal tube malfunction at any point during their care, from first patient contact at the sending facility, through the flight, and until transfer of care at the receiving facility.
Incidence of adverse events related to tracheal tube cuffs in the transport setting. [ Time Frame: Any point during care. ] [ Designated as safety issue: Yes ]
The flight paramedics will identify if there has been an adverse event related to tracheal tube cuff at any point during their care, from first patient contact at the sending facility, through the flight, and until transfer of care at the receiving facility.

Estimated Enrollment:	320
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saline in tube cuff Use of sterile saline to inflate tracheal tube cuff	Other: Saline in tube cuff Use of sterile saline, instead of air, to inflate tracheal tube cuff. Tracheal tube cuffs to be inflated to 22-25 cm H2O. Other Name: Sterile saline to inflate tracheal tube cuff.
No Intervention: Air in tube cuff No intervention (control) - patient cohort, using air to inflate tracheal tube cuff.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

interfacilty patient transfer
cuffed tracheal tube
age equal to or greater than 18 years
planned flight time >20 minutes (helicopter) / >30 minutes (fixed wing)

Exclusion Criteria:

age less than 18 years
other advaced airway (non-tracheal tube)
scene response
planned flight time less than 20 minutes (helicopter) / 30 minutes (fixed wing)
medical condition that requires cabin altitude less than 1000 feet above ground level

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384500

Contacts

Contact: Russell MacDonald, MD MPH	647 428 2034	rmacdonald@ornge.ca
Contact: Mahvareh Ahghari, MEng	647 428 2092	mahghari@ornge.ca

Locations

Canada, Ontario
Ornge Transport Medicine	Recruiting
Mississauga, Ontario, Canada, L4W5H8
Contact: Russell MacDonald, MD MPH 647 428 2034 rmacdonald@ornge.ca
Contact: Mahvareh Ahghari, MEng 647 428 2092 mahghari@ornge.ca
Sub-Investigator: Matthew Turnock, MSc
Sub-Investigator: Jodie Pritchard

Sponsors and Collaborators

Ornge Transport Medicine

Investigators

Principal Investigator:

Russell MacDonald, MD MPH

Ornge Transport Medicine

More Information

No publications provided

Responsible Party:	Dr. Russell MacDonald, Medical Director, Ornge Transport Medicine
ClinicalTrials.gov Identifier:	NCT01384500 History of Changes
Other Study ID Numbers:	098-2011
Study First Received:	June 20, 2011
Last Updated:	July 15, 2011
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Barotrauma
Wounds and Injuries

ClinicalTrials.gov processed this record on May 21, 2013

The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial (OCTOPUS)