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Trial registered on ANZCTR


Registration number
ACTRN12615000081516
Ethics application status
Approved
Date submitted
8/01/2015
Date registered
30/01/2015
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cuffed Versus Uncuffed Endotracheal Tubes for Ventilation of Neonates and Infants in the Neonatal and Paediatric Intensive Care Unit: A Pilot RCT
Scientific title
Cuffed Versus Uncuffed Endotracheal Tubes for Ventilation of Neonates and Infants in the Neonatal and Paediatric Intensive Care Unit: A Pilot study to show the efficacy of cuffed endotracheal tubes for longer term ventilation
Secondary ID [1] 285931 0
Nil
Universal Trial Number (UTN)
U1111-1165-8549
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Artificial ventilation in neonates and infants 293855 0
Condition category
Condition code
Anaesthesiology 294159 294159 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing cuffed endotracheal tubes (Microcuff (registered trademark) tube) versus traditional tubes for longer term artificial ventilation in neonates and infants in the neonatal/ paediatric intensive care setting.
The Microcuff (registered trademark) 3.0mm tube has a cuff made of ultrathin polyurethane, which when inflated makes it's seal in the trachea. The tube will be in place until the patient is ready for extubation.
Intervention code [1] 290904 0
Treatment: Devices
Comparator / control treatment
Standard uncuffed endotracheal tube. Portex (registered trademark) siliconised 3.0-3.5mm endotracheal tube which makes it's seal in the cricoid. The tube will be in place until the patient is ready for extubation.
Control group
Active

Outcomes
Primary outcome [1] 293951 0
Ability to sustain the ETT leak within the desirable range of 10-20% when using the Microcuff (registered trademark) ETT compared to the use of uncuffed ETTs. The ETT leak is measured as a ventilator readout.
Timepoint [1] 293951 0
The outcome will be assessed from initial intubation and artificial ventilation to the time of successful extubation. Successful extubation is defined as 12 hours post extubation where the patient is free of symptoms of upper airway swelling or lung disease requiring re-intubation.
Secondary outcome [1] 312221 0
Airway swelling/ damage.
Measured by extubation laryngoscopy, need for dexamethasone/ nebulised adrenaline and reintubation.
Timepoint [1] 312221 0
From time of extubation to 12 hours symptom free.
Secondary outcome [2] 312398 0
Efficacy of ventilation.
Timepoint [2] 312398 0
Measured by FiO2 requirement, PIP/ MAP/ PEEP requirements, oxygenation index, whether VG/ VC ventilation was ceased due to large air leak, days ventilated, episodes of atelectasis radiographically, episodes of pneumonia, episodes of tube blockage, re-intubations.

Eligibility
Key inclusion criteria
Neonates >35/40 gestation and >3kg in weight and infants <3 months of age.
Medical and surgical patients.
Expected to require ventilation for >12 hours.
Minimum age
0 Hours
Maximum age
3 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ex-preterm infants (<32/40 at birth) who received an ETT in that first admission in the NICU.
Known or suspected airway abnormality.
Intubation happening in neonates on non-metropolitan retrievals via RFDS.
Parents refused consent.

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)
Parents of all eligible patients who may require intubation in the near future and are to be admitted or are already admitted to NICU and PICU and who fulfil the inclusion/ exclusion criteria will be approached for consent if practical to do so. This ideally will happen on transport retrieval for those whose parents are not travelling with their children or on admission to the unit. Those going for routine surgery will be approached well in advance of going to theatre. Written informed consent will be obtained.

In the case of an emergency intubation in a neonate or infant who is eligible for the trial, they will be enrolled in the trial and randomised, with delayed consent from the parents following the procedure. If the parents do not wish to continue in the trial, no data will be collected on their child. The same tube will continue to be used unless there is a clinical reason to change the tube as changing the tube confers an unnecessary risk to the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated using computer generated random numbers by MinimPy. Study population will be stratified as NICU and PICU patients by using a location variable with the MinimPy program. This should reduce both bias in age, type of ventilator used and normal protocols/ care for the different units. Stratification will also be done based on whether the patient has a medical or a surgical condition requiring ventilation. The allocation to either Cuffed or un-Cuffed produced by MinimPy program will be sealed in a opaque envelope. The sealed opaque envelopes containing the allocation type will be opened only immediately prior to the procedure of endotracheal intubation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analysis was performed using Stata v15 software (StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX: StataCorp LLC). For normally distributed continuous data, groups were compared using independent sample t-test. For data with skewed distribution, Wilcoxon rank sum test was planned to be used. For categorical variables, groups were compared using chi-squared with Fishers exact p-value. Results for binary outcomes were presented as odds ratio (OR) with corresponding 95% confidence intervals. For comparison of continuous outcomes, we used mean difference with accompanying 95% confidence intervals (CI). All tests were two-sided and a P value of <0.05 was considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3305 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 9089 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 290515 0
Charities/Societies/Foundations
Name [1] 290515 0
Channel 7 Telethon
Address [1] 290515 0
PO Box 50, Tuart Hill WA 6939
Country [1] 290515 0
Australia
Funding source category [2] 290516 0
Hospital
Name [2] 290516 0
Princess Margaret Hospital
Address [2] 290516 0
Roberts Road, Subiaco, WA 6008
Country [2] 290516 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Road, Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 289209 0
None
Name [1] 289209 0
Address [1] 289209 0
Country [1] 289209 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292166 0
Human Research Ethics Committee (HREC), Princess Margaret Hospital
Ethics committee address [1] 292166 0
Roberts Road,
Subiaco,
WA 6008
Ethics committee country [1] 292166 0
Australia
Date submitted for ethics approval [1] 292166 0
Approval date [1] 292166 0
23/12/2014
Ethics approval number [1] 292166 0
2014111EP

Summary
Brief summary
The purpose of this pilot study is to show the efficacy of using cuffed endotracheal tubes (ETT) for longer term ventilation in neonates >3kg and infants <3 months in the neonatal and paediatric intensive care setting.

Cuffed ETTs potentially offer the advantage of a less or more manageable air leak and therefore improved ventilation. This is extremely relevant in theatre and in the intensive care unit (ICU) where inflammation, fluid shifts and changes in lung compliance result in dynamic changes.

There has been much debate in recent years over the use of cuffed versus uncuffed ETTs for the ventilation of neonates, infants and children. Traditionally, uncuffed ETTs have been used due to historical, unsubstantiated concerns over the safety of using cuffed ETTs in small children. However, over the last few years with the advent of the newer high-volume low-pressure cuffed tubes (HVLP), there has been an increase in the use of cuffed tubes in children from birth (>3kg) particularly during anaesthesia for surgical procedures. There has also been an increase in use for longer term ventilation in the PICU.

Our hospital is now using cuffed ETTs in small children from birth for anaesthesia in theatre and they are also commonly used in PICU. They are sometimes being used in term neonates in the NICU when they come back from theatre with one in place.

Most of the data available in the literature concerns short term use of cuffed ETTs in the anaesthetic setting, but data supporting the use of cuffed or uncuffed tubes for longer term ventilation in neonates and infants is poorly studied.

It is an important question as complications with regard to inadequate ventilation contribute to prolonged hospital stay and inappropriate tube selection and multiple tube changes contribute to airway trauma potentially requiring airway reconstruction inferring a high cost to the patient and health care system.

This is a pilot RCT to begin the process of bringing some proper scientific rigor to the subject. It will take place at PMH in 6B (NICU) and PICU with the involvement of anaesthetics when the tube is placed in theatre. It will include neonates >3kg and infants up to 3 months of age.

Patients will be randomised to receive a cuffed or uncuffed ETT and then data will be collected to look at the primary outcome of tube leak. The secondary objective is to show comparable or improved safety and improvement in the ability to ventilate with cuffed ETTs when compared with uncuffed ETTs.

With this initial study, we hope to show that safety and efficacy is at least on a par with the traditional uncuffed ETTs and maybe a trend towards improved ventilation. With these initial results, we will go on to set up a larger multi-centre RCT to look at the outcomes in more detail.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53858 0
Dr Rebecca Thomas
Address 53858 0
NICU, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 53858 0
Australia
Phone 53858 0
+61 8 64565402
Fax 53858 0
Email 53858 0
Rebecca.Thomas4@health.wa.gov.au
Contact person for public queries
Name 53859 0
Dr Rebecca Thomas
Address 53859 0
NICU, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 53859 0
Australia
Phone 53859 0
+61 8 64565402
Fax 53859 0
Email 53859 0
Rebecca.Thomas4@health.wa.gov.au
Contact person for scientific queries
Name 53860 0
Dr Rebecca Thomas
Address 53860 0
NICU, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, WA 6009
Country 53860 0
Australia
Phone 53860 0
+61 8 64565402
Fax 53860 0
Email 53860 0
Rebecca.Thomas4@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All collected
When will data be available (start and end dates)?
For 10 years from publication
Available to whom?
Upon request to CPI. Case-by-case basis. Will be granted to those who provide a methodologically sound proposal.
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Subject to approval of principal investigator
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary