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Trial registered on ANZCTR


Registration number
ACTRN12624000193572
Ethics application status
Approved
Date submitted
20/01/2024
Date registered
28/02/2024
Date last updated
28/02/2024
Date data sharing statement initially provided
28/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Air or saline to fill breathing tube cuffs for ventilated children during flight
Scientific title
A comparison of the pressures inside paediatric endotracheal cuffs filled with air or saline during aeromedical transport
Secondary ID [1] 311378 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BestCuff
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric respiratory support during aeromedical transport 332647 0
Condition category
Condition code
Anaesthesiology 329354 329354 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327821 0
Treatment: Devices
Comparator / control treatment
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. The control group of this study will have the cuff of the tracheal tube filled with saline.
Control group
Active

Outcomes
Primary outcome [1] 337174 0
Change in pressure within the tracheal tube cuff
Timepoint [1] 337174 0
Baseline, every two minutes during ascent and descent, every ten minutes at cruising altitude. For every patient the pressure will be measured throughout the entire flight, so the duration of measurement will equal the duration of flight time.
Secondary outcome [1] 430970 0
Nil
Timepoint [1] 430970 0
Nil

Eligibility
Key inclusion criteria
Mechanically ventilated patients who have been intubated with a cuffed tracheal tube, who have been referred to the Starship PICU NZ national paediatric transport service.
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The mean pressures recorded in saline and air-filled cuffs on ascent, cruising and descent will be compared using balanced one-way ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26090 0
New Zealand
State/province [1] 26090 0

Funding & Sponsors
Funding source category [1] 315636 0
Self funded/Unfunded
Name [1] 315636 0
Country [1] 315636 0
Primary sponsor type
Hospital
Name
Starship Hospital
Address
Grafton Road, Grafton, Auckland
Country
New Zealand
Secondary sponsor category [1] 317735 0
None
Name [1] 317735 0
Address [1] 317735 0
Country [1] 317735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314520 0
New Zealand Northern B Health and Disability Ethics Committee
Ethics committee address [1] 314520 0
Health and Disability Ethics Committees, Ministry of Health, 133 Molesworth Street, PO Box 5013, Wellington 6011
Ethics committee country [1] 314520 0
New Zealand
Date submitted for ethics approval [1] 314520 0
23/01/2023
Approval date [1] 314520 0
25/01/2023
Ethics approval number [1] 314520 0
2023 FULL 13213

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131874 0
Dr Chris Hands
Address 131874 0
Department of Critical Care Medicine, Auckland City Hospital, 2 Park Road, Grafton, Auckland 1010
Country 131874 0
New Zealand
Phone 131874 0
+64 225897110
Fax 131874 0
Email 131874 0
[email protected]
Contact person for public queries
Name 131875 0
Chris Hands
Address 131875 0
Department of Critical Care Medicine, Auckland City Hospital, 2 Park Road, Grafton, Auckland 1010
Country 131875 0
New Zealand
Phone 131875 0
+64 225897110
Fax 131875 0
Email 131875 0
[email protected]
Contact person for scientific queries
Name 131876 0
Chris Hands
Address 131876 0
Department of Critical Care Medicine, Auckland City Hospital, 2 Park Road, Grafton, Auckland 1010
Country 131876 0
New Zealand
Phone 131876 0
+64 225897110
Fax 131876 0
Email 131876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21448Study protocol    387204-(Uploaded-20-01-2024-16-59-04)-Study-related document.docx



Results publications and other study-related documents

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