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.

A tracheostomy is an artificial airway inserted into the trachea (windpipe) through the front of the neck, usually required for prolonged artificial ventilation in the critically ill. Between 10-15% of the 250,000 patients admitted annually to UK Intensive Care Units (ICUs) require temporary tracheostomy, with an additional 5,000 tracheostomies performed during surgery. The tubes have a cuff/balloon which seals the trachea when inflated, allowing lung ventilation. The flow of gas into and out of the patient's lungs does not flow through the upper airways (nose and mouth), bypassing the larynx (voice box) and preventing speech. Our research found the biggest problem with tracheostomies from the patient's perspective is losing the ability to speak. If the muscles of the larynx and throat are not used, they quickly become weak, meaning that coughing, swallowing and talking can take longer to recover. These problems cause anger, frustration, fear and low mood and lead to significantly longer hospital stays, impacting ICU and hospital bed availability.

Patients with a weak cough or swallow cannot clear secretions from the throat, which may enter the lungs (aspiration). The inflated cuff reduces aspiration and most ICU-specific tubes have an extra suction-port for secretion removal. However, additional gas can be directed via the suction-port, through the vocal cords and out via the upper airways, allowing vocalisation. The MHRA confirmed these tubes can be used for 'above cuff voicing' (ACV) in line with their CE marking.

Our proposed research advances healthcare technologies by developing a new clinically validated prototype medical device with the potential to significantly increase patient benefit for a defined and expanding area of clinical need. Our collaborative project combines our clinical experience and understanding of the needs of tracheostomy patients and their families with the design and engineering excellence of our University and SME partners. Our team is supported by individual and institutional research expertise and together with our patient partners, we can deliver an advanced prototype device with a clear pathway towards adoption and commercialisation, attractive to follow-on funders and investors.

Inclusion Criteria:

Inclusion criteria (patient):

• 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.

Exclusion Criteria:

Exclusion criteria (patient): Participants must not enter the study if any of the following exclusion criteria are fulfilled:

• 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.

The project will generate confidential patient data and commercially sensitive IP data. Summaries of these data will be shared publicly.