NCT04647786

Safe and Effective Above Cuff Tracheostomy Ventilation

Safe and Effective Above Cuff Tracheostomy Ventilation - a Device Development Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Manchester University NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tracheostomy

Interventions

Type	Name	Description
DEVICE	Prototype medical device (SEA CtV)	A prototype device that delivers a controlled flow of gas to the upper airways via the subglottic suction port of an established tracheostomy tube. Gas flow may be timed, warmed and/or humidified.

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-12-01
• Last updated: 2025-01-20

Locations

1 site across 1 country: United Kingdom