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Tracheostomy fenestration: Does it increase upper airway flow?

Tracheostomy fenestration in patients with head and neck cancer: Does it increase upper airway flow?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001384842
Enrollment
28
Registered
2021-10-14
Start date
2019-03-04
Completion date
2021-10-11
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Royal Adelaide Hospital ENT department
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026