SEA CtV

• Research type

  Research Study

• Full title

  Safe and Effective Above Cuff Tracheostomy Vocalisation (SEA CtV)

• IRAS ID

  278006

• Contact name

  Brendan McGrath

• Contact email

  brendan.mcgrath@manchester.ac.uk

• Sponsor organisation

  Manchester University NHS Foundation Trust

• Clinicaltrials.gov Identifier

  NCT04647786

• Duration of Study in the UK

  1 years, 9 months, 30 days

• Research summary

  Tracheostomies are small plastic tubes inserted into the neck, used most commonly in the Intensive Care Unit (ICU) for patients who are weak, or who need breathing support from a ventilator. Around 20,000 new tracheostomies are inserted in the UK each year, with around two-thirds in ICU patients.

  Patients tell us when they wake up with a tracheostomy, the worst thing is not being able to speak. Tubes have a balloon or cuff which 'seals off' the upper airway (nose and mouth) meaning that gas breathed in and out does not flow through the larynx (voice-box). Patients can be fully awake and yet unable to speak

  Our project aims to get patients with new tracheostomies talking earlier in their treatment, by developing a safe and effective system to deliver gas flows 'above the cuff' of the tube, and out of the mouth via the voice-box.

  We call this technique 'Above Cuff Vocalisation' or ACV. We can only currently deliver ACV using a continuous flow of cold, dry gas, without safety features. The first two years of this project involves designing and testing a new product to safely deliver warm, moist gas for ACV, delivered when the patient wants to speak, and ensuring patient comfort.

  The final year of the project tests routine ACV with our prototype against standard care (no ACV). We will work with patients, doctors, nurses and speech and language therapists to record the effect that our device has on:

  1. Talking: can patients talk earlier and with a better voice?
  2. Eating: can patients swallow earlier?
  3. Stress and worry
  4. Time spent in ICU or in hospital

  By the end of this project, we aim to have developed a carefully tested (clinically validated) prototype medical device that is able to safely and effectively deliver ACV, helping patients to communicate and speeding up their recovery.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  22/NW/0022

• Date of REC Opinion

  4 Mar 2022

• REC opinion

  Further Information Favourable Opinion