The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial

NCT01384500 | Withdrawn DMC

• 1 other identifier: 098-2011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Injury of Trachea; Friction and Pressure Injuries; Barotrauma; Transfer/Transport Injury

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the incidence of tracheal tube cuff pressure exceeding 30 cm H2O during the cruise portion of flight.

  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.

  During cruise portion of flight, approximately 10-15 minutes after aircraft take-off.

Secondary Outcomes (4)

• Incidence of tracheal tube cuff pressure exceeding 30 cm H2O on initial inflation of the cuff prior to departure from sending facility.

  Prior to departure from sending facility

• The change in cuff pressure from ground to in flight at cruising altitude.

  During cruise portion of flight.

• The incidence of cuff leak or other tracheal tube malfunction.

  Any point during care

• Incidence of adverse events related to tracheal tube cuffs in the transport setting.

  Any point during care.

Study Arms (2)

Saline in tube cuff

EXPERIMENTAL

Use of sterile saline to inflate tracheal tube cuff

Other: Saline in tube cuff

Air in tube cuff

NO INTERVENTION

No intervention (control) - patient cohort, using air to inflate tracheal tube cuff.

Interventions

Saline in tube cuff OTHER

Use of sterile saline, instead of air, to inflate tracheal tube cuff. Tracheal tube cuffs to be inflated to 22-25 cm H2O.

Also known as: Sterile saline to inflate tracheal tube cuff.

Saline in tube cuff

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ornge Transport Medicine: lead

Study Sites (1)

Ornge Transport Medicine

Mississauga, Ontario, L4W5H8, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer; Barotrauma

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Russell MacDonald, MD MPH

  Ornge Transport Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

CA (1)