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Tracheostomy

Safe and Effective Above Cuff Tracheostomy Ventilation

Sponsored by Manchester University NHS Foundation Trust

About this trial

Last updated 2 years ago

Study ID

B00990

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

A Phase I study of an 'in-house' developed, novel, Class I, prototype medical device to facilitate vocalisation in participants with cuff-inflated tracheostomy tubes. Primary objective: To design and develop a device to deliver Above Cuff Vocalisation (ACV) that is safe, well tolerated and effective at producing a voice in tracheostomised patients in the Intensive Care Unit (ICU). Secondary objective: To evaluate whether more effective delivery of ACV has a significant impact on laryngeal function and recovery following new tracheostomy in ICU patients.

What are the participation requirements?

Yes

Inclusion Criteria

- Provision of informed consent prior to any study specific procedures

- cuff-inflated tracheosotmy tube in situ for >48 hours

- managed on an Intensive Care Unit at MFT

- Male and females

- Aged 18-100; patient is alert and attempting to communicate (and thus able to participate in the consent process). Inclusion criteria (staff):

- Provision of informed consent

- bedside clinical staff (medical, nursing, allied healthcare professional) who manage the patient during routine clinical duties whilst ACV is in progress.

No

Exclusion Criteria

- Patient refusal

- ACV is not indicated in the opinion of the parent clinical team

- Patient has (or is suspected to have) an altered and therefore potentially obstructed upper airway

- Patient has (or is suspected to have) an active and currently infectious high-consequence respiratory infection that could be transmitted by aerosolisation (eg COVID-19)

- Clinical condition has progressed so that the patient is tolerating cuff deflation and a speaking valve well and is able to voice effectively (ie without ACV: this negates the requirement for an ACV trial); Contraindications to FEES (adapted from RCSLT FEES policy) o Base of skull / facial fracture; Severe/life threatening epistaxis within the last 6 weeks; Trauma to nasal cavity secondary to surgery or injury within the last 6 weeks; Sino-nasal and anterior skull base tumours / surgery; Nasopharyngeal stenosis; Craniofacial anomalies; Hereditary Haemorrhagic telangiectasia Exclusion criteria (staff): Refusal to participate.

Locations

Location

Status

Recruiting