Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001384842
Ethics application status
Approved
Date submitted
12/08/2021
Date registered
14/10/2021
Date last updated
20/09/2022
Date data sharing statement initially provided
14/10/2021
Date results information initially provided
20/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tracheostomy fenestration: Does it increase upper airway flow?
Scientific title
Tracheostomy fenestration in patients with head and neck cancer: Does it increase upper airway flow?
Secondary ID [1] 298618 0
Nil known
Universal Trial Number (UTN)
U1111-1236-0800
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tracheostomy 313476 0
Head and neck cancer 313477 0
Condition category
Condition code
Cancer 311905 311905 0 0
Head and neck
Respiratory 321190 321190 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a randomised crossover comparison of fenestrated and non-fenestrated inner cannulas in a corked, uncuffed fenestrated double lumen tracheostomy tube. Specifically:

(a) Participants will have their inner cannula changed by the primary investigator on four occasions following successful tracheostomy occlusion

(b) Inner cannulas (fenestrated and non-fenestrated) will be changed two times each (4 separate occasions), with each in-situ for 60 minutes following the change. The order of change will be randomised to ABAB or BABA, where A=fenestrated and B=non-fenestrated. Data collection (via spirometry and digital voice recording) will take place 60 minutes following each change, immediately prior to the next change. Data collection will therefore be completed in 4 hours.

(c) The primary investigator (speech pathologist) will be administering the intervention.

(d) The key difference between the fenestrated and non-fenestrated inner cannulas are that the fenestrated cannula has a hole (fenestration) in the outer curve that when in-situ is aligned with the fenestration of the outer cannula. As such, air can pass through the fenestration of the outer tube when the fenestrated inner cannula is in-situ, but not when the non-fenestrated inner cannula is in-situ (as the outer fenestration will be blocked). This is why the protocol is a crossover comparison of inner cannulas within a fenestrated outer cannula, in order to measure the difference in airflow with the fenestration open or closed.

(e) Nursing / medical records will be consulted (and discussion with the treating nurse) to ensure that there are no deviations to the protocol in between testing. A deviation could be that the cork/cap is removed by the patient due to difficulty breathing.

There is a 60 minute period following each inner cannula change before the assessments are performed.
Intervention code [1] 314876 0
Treatment: Devices
Comparator / control treatment
The patient is their own control. The intervention is the fenestrated inner cannula and the comparator in this study is the non-fenestrated inner cannula.
Control group
Active

Outcomes
Primary outcome [1] 320570 0
Any change in peak expiratory flow (PEF) using spirometry
Timepoint [1] 320570 0
The patient is enrolled within 24 hours following successful tracheostomy corking/occlusion.
The inner cannulas are changed on 4 occasions, 60 minutes apart.
There are 4 assessment points, 60 minutes following each cannula change.
Measures of PEF are obtained 3 times during each assessment point, with the highest PEF recorded for analysis.
Primary outcome [2] 320571 0
Any change in maximum phonation time (MPT) assessed by digital voice recording with a timer.
Timepoint [2] 320571 0
The patient is enrolled within 24 hours following successful tracheostomy corking/occlusion.
The inner cannulas are changed on 4 occasions, 60 minutes apart.
There are 4 assessment points, 60 minutes following each cannula change.
Measures of MPT are obtained 3 times during each assessment point, with the longest MPT recorded for analysis.
Secondary outcome [1] 372082 0
Incidence of fenestration malposition will be recorded. This is directly visualised via tracheoscopy through the tracheostomy tube.
Timepoint [1] 372082 0
Following the participant's tracheostomy tube change from cuffed to an uncuffed fenestrated tracheostomy, and once the participant is successfully tolerating tracheostomy occlusion, the participant will be consented for enrolment. Following enrolment in the study, the order of inner cannula insertion will be randomised and allocated. On initial inner cannula insertion/change, the fenestration will be visualised.

Eligibility
Key inclusion criteria
Any adult patient with Head and Neck cancer who has an uncuffed fenestrated tracheostomy in-situ, and who is able to tolerate corking (that is, prolonged occlusion of the tracheostomy tube via a cork or cap).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to tolerate corking (prolonged tube occlusion)
Patients unable to participate in spirometry due to inadequate lip seal
Moribund patients, unlikely to survive hospital admission
Patients with cognitive impairment who are unable to consent or follow instructions

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)
Allocation concealed by central randomisation by computer
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Sample size was calculated using the Wilcoxon non-parametric test. Assuming an effect size of 0.5 (with each patient as their own control and using a paired test at the end) - e.g. to detect a difference of 30 L/min with SD of 60 L/min, then we will need 28 patients.

Period, sequence and carry-over effects will be generated using generalized estimating equations, adjusted for within patient correlation and treatment order.

A two sample t-test using either the sum or the difference between each patient’s outcome will be used for both the primary outcome (PEF) and secondary outcome (MPT),

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
22/10/2021
Actual
11/10/2021
Date of last data collection
Anticipated
22/10/2021
Actual
11/10/2021
Sample size
Target
28
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 14116 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 26917 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 303159 0
Charities/Societies/Foundations
Name [1] 303159 0
Royal Adelaide Hospital Allied Health Grant
Country [1] 303159 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital ENT department
Address
Royal Adelaide Hospital ENT department
1 Port Rd, Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 303158 0
None
Name [1] 303158 0
Address [1] 303158 0
Country [1] 303158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303721 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 303721 0
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia, 5000
Ethics committee country [1] 303721 0
Australia
Date submitted for ethics approval [1] 303721 0
11/12/2018
Approval date [1] 303721 0
31/01/2019
Ethics approval number [1] 303721 0
R20190117

Summary
Brief summary
The purpose of this study is to see if a tracheostomy tube that has a window (called a fenestration) can increase airflow through the upper airway and improve speech when compared to tubes that don't have the window, in patients having surgery.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with a head and neck cancer, and as part of your surgical management have an uncuffed fenestrated tracheostomy in-situ.

Study details
Patients will be first randomised to either the intervention (fenestrated inner tube) or the control (non-fenestrated inner tube), however all participants will experience both the intervention and the control at some point in time.

The interventions will involve changing the inner tubes and seeing an effect on upper airflow. The study will involve several tests, including directly looking at where the fenestration (or, window) sits in the trachea.

It is hoped this research will demonstrate that fenestrated tubes can improve airflow and therefore make it easier for patients to speak.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94566 0
Dr Lee Pryor
Address 94566 0
Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000
Country 94566 0
Australia
Phone 94566 0
+61 415 565 591
Fax 94566 0
Email 94566 0
[email protected]
Contact person for public queries
Name 94567 0
Dr Lee Pryor
Address 94567 0
Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000
Country 94567 0
Australia
Phone 94567 0
+61 415 565 591
Fax 94567 0
Email 94567 0
[email protected]
Contact person for scientific queries
Name 94568 0
Dr Lee Pryor
Address 94568 0
Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000
Country 94568 0
Australia
Phone 94568 0
+61 415 565 591
Fax 94568 0
Email 94568 0
[email protected]

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 of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo 1. Research question The aim of the study was to ... [More Details]

Documents added automatically
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