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The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial

NCT01384500 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-09-29

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ornge Transport Medicine

    lead OTHER

Principal Investigators

  • Russell MacDonald, MD MPH · Ornge Transport Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01384500 on ClinicalTrials.gov