ANZCTR - Registration

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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 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]

Nil known

Universal Trial Number (UTN)

U1111-1236-0800

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tracheostomy

Head and neck cancer

Condition category

Condition code

Cancer

Head and neck

Respiratory

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]

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]

Any change in peak expiratory flow (PEF) using spirometry

Timepoint [1]

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]

Any change in maximum phonation time (MPT) assessed by digital voice recording with a timer.

Timepoint [2]

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]

Incidence of fenestration malposition will be recorded. This is directly visualised via tracheoscopy through the tracheostomy tube.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Adelaide Hospital Allied Health Grant

Address [1]

Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network HREC

Ethics committee address [1]

Royal Adelaide Hospital 
1 Port Rd, Adelaide 
South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/12/2018

Approval date [1]

31/01/2019

Ethics approval number [1]

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

Dr Lee Pryor

Address

Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000

Country

Australia

Phone

+61 415 565 591

Fax

lee.pryor@sa.gov.au

Contact person for public queries

Name

Lee Pryor

Address

Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000

Country

Australia

Phone

+61 415 565 591

Fax

lee.pryor@sa.gov.au

Contact person for scientific queries

Name

Lee Pryor

Address

Speech Pathology Department
Royal Adelaide Hospital
1 Port Rd, Adelaide
South Australia 5000

Country

Australia

Phone

+61 415 565 591

Fax

lee.pryor@sa.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 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: lee.pryor@sa.gov.au

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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