Clinical Trial: The Ornge Comparison of Tracheal Occlusion Pressures to Ensure Safety Trial

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.

Detailed Summary:

Introduction Air medical services routinely transport patients who are intubated and mechanically ventilated. Transporting this patient population is safe but patients subject to changes in barometric pressure in flight. Aircraft used typically maintain a cabin pressures of 3000 to 7000 feet above sea level. This compares to commercial aircraft that maintain cabin pressures of 5000 to 8000 feet. A known volume of gas will expand as the ambient pressure decreases. If the gas cannot expand, pressure exerted by the gas in an enclosed space will increase. An aircraft cabin with an ambient pressure of 3000 to 7000 feet altitude results in a 9 to 23% decrease in ambient pressure compared to sea level. Tracheal tube cuffs are subject to changes in ambient pressure that occur in transport. Tracheal tube cuffs minimize the risk of tracheal mucosal injury, but high pressures occur. A recent series of intubated adult patients undergoing transfer by helicopter showed that 58% had initial pressures greater than 40 cm H2O . A subsequent study revealed pressures exceeding 40 cm H2O in two thirds of patients and 30 cm H2O in nearly three quarters. There is a risk because tracheal mucosa blood flow is compromised at 30 cm H2O, and ceases at lateral wall pressures of 50 cm H2O. These high pressures can result in complications ranging from sore throat to major complications such as tracheal ischemia and fistula formation. To avoid tracheal injury and related complications, tracheal tube cuff pressures should be maintained at less than 30 cm H2O.

Sterile saline to inflate the cuff can decrease risk because it is not compressible or subject to atmospheric pressure changes as much as gases. Saline causes less cuff pressure increase and tracheal morbidity in the operating room, avoids excessive pressure due to changes in altitude, and is safe in transport. However, the ability of saline to prev
Sponsor: Ornge Transport Medicine

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]
  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. ]
  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 ]
  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. ]
  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.

Original Secondary Outcome: Same as current

Information By: Ornge Transport Medicine

Dates:
Date Received: June 20, 2011
Date Started: July 2011
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016