RecruitingACTRN12624000193572

Air or saline to fill breathing tube cuffs for ventilated children during flight

A comparison of the pressures inside paediatric endotracheal cuffs filled with air or saline during aeromedical transport


Sponsor

Starship Hospital

Enrollment

40 participants

Start Date

May 2, 2024

Study Type

Interventional

Conditions

Summary

Historically the cuffs of endotracheal tubes of mechanically ventilated children have been filled with saline prior to aeromedical transport in order to limit increases in pressure during ascent, although some paediatric and neonatal transport services in Australasia fill the cuffs with air and periodically monitor the cuff pressure. There are data to demonstrate the pressure changes at altitude associated with different strategies for tracheal tube cuff inflation in artificial tracheal models in adults and children. However there are few paediatric data derived from patient observations to describe the pressure changes that occur in a patient’s trachea at altitude with air-filled or saline-filled tracheal tube cuffs. This study will provide objective data on the changes in endotracheal tube cuff pressure in mechanically ventilated patients during ascent, cruising and descent, in cuffs filled with air and saline. This will allow the development of evidence-based protocols for the management of paediatric endotracheal tube cuffs during aeromedical transport.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

When sick children on breathing machines (mechanical ventilators) are transported by air ambulance, the cuff — the small inflatable balloon on the breathing tube that seals the airway — can change in pressure as the aircraft ascends and descends. Some transport teams fill these cuffs with saline (saltwater) to prevent pressure changes, while others use air and monitor pressure during the flight. Both approaches are currently used, but real-world data from paediatric patients is scarce. This study will measure and compare cuff pressures in mechanically ventilated children during air transport, with cuffs filled with either air or saline. The data will be used to develop evidence-based guidelines for managing breathing tube cuffs during paediatric aeromedical transport, improving safety for critically ill children during flight. Eligible participants are mechanically ventilated children under 15 years who are being transported by the Starship PICU national paediatric transport service in New Zealand. There are no exclusion criteria for this study.

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Interventions

Tracheal tubes used for mechanical ventilation in critically ill paediatric patients are often fitted with a cuff. Cuffed tubes are less likely to be used in younger patients, but their use becomes in

Tracheal tubes used for mechanical ventilation in critically ill paediatric patients are often fitted with a cuff. Cuffed tubes are less likely to be used in younger patients, but their use becomes increasingly likely over the age of one year. The cuff is inflated with air following endotracheal intubation. Cuff pressures are measured as part of standard care in intensive care units, as a high pressure in the cuff entails a risk of damaging the tracheal mucosa. Blood flow in the tracheal wall is compromised at cuff pressures greater than 30cmH2O and ceases at the critical perfusion pressure of 50cmH2O. Aeromedical transport introduces a new risk, as during ascent there may be rapid change of the relative pressures of the gas in the cuff and the surrounding atmosphere, leading to very high pressures inside the cuff. The intervention group in this study will have the cuff of the tracheal tube filled with air. The intervention will last for the duration of the aeromedical transport, which will be between 1 and 3 hours. The intervention will be delivered by the transport team, which will consist of a PICU registrar and a PICU transport nurse. A log will be kept of which patients eligible for transport are randomised to the intervention or to standard care.


Locations(1)

New Zealand

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ACTRN12624000193572