A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies

NCT06027866 | Completed Results

• 1 other identifier: B22/04
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Patients in acute and critical care often undergo a tracheostomy. A tracheostomy is an incision at the front of the neck to insert a breathing tube directly into the airway. The tube sits in place in the airway using an inflated air-filled cuff. This means that no airflow is directed up and out past the vocal cords through the voice box, and speech is not possible. Being unable to speak can cause distress to patients and may place them at an increased risk of harm if they are unable to express their wishes or needs. It can also increase stress for relatives and healthcare staff as they try to understand what patients are trying to say. Usually when patients cannot talk, staff use different items to help, like a pen and paper. A new communication device that runs on a smartphone or tablet has recently been developed. It is for patients with tracheostomies and works by reading lip movements and translating them into words on the device screen. The aim of this study is to find out if providing adult acute and critical care patients who have a tracheostomy with the use of this lip-reading device could improve how they communicate. This study will include:

1. 1.Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better.
2. 2.Interviews with patients, relatives and focus groups/interviews with staff to find out their views on communication including the use of the new lipreading device.
3. 3.Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health.

Conditions

Tracheostomy; Communication; Acute/Critical Illness

Outcome Measures

Primary Outcomes (2)

• Number of Participants Using SRAVI at Least Once

  From date of study enrolment until SRAVI no longer required by participant (due to return of natural voice) whilst in the study site or participant has been discharged from study site, an average of 8 weeks.

• Number of Words/Phrases Correctly Identified by SRAVI App

  From study enrolment until SRAVI no longer required by participant (due to return of natural voice) whilst in study site or participant has been discharged from study site, an average of 8 weeks.

Secondary Outcomes (7)

• Length of Critical Care Stay

  From critical care admission to critical care discharge, censored at 8-weeks

• Duration of Hospital Length of Stay

  From hospital admission to hospital discharge, censored at 3-months

• Count of Participants With Delirium During Critical Care Stay

  Assessed twice per shift using the validated delirium screening tool used in each unit from date of study enrolment until SRAVI no longer used or discharge from critical care. Censored at 8-weeks

• Health Related Quality of Life

  Three months following acute/critical care discharge

• Number of Patients Experiencing Symptoms of Anxiety and Depression

  Three months following acute/critical care discharge

Study Arms (1)

Tracheostomy patients

All consenting participants will receive access to SRAVI (Speech Recognition Application for the Voice Impaired), a communication aid for speech-impaired patients. SRAVI is a software-based mobile application ('app') and can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). SRAVI has been registered with the Medical and Healthcare products Regulatory Agency (MHRA) and CE marked for intended use. SRAVI is based on Visual Speech Recognition (VSR) technology. Specifically, the LipRead technology can determine speech by analysing the movements of a user's lips as they speak into a camera.

Device: SRAVI (Speech Recognition Application for the Voice Impaired)

Interventions

SRAVI (Speech Recognition Application for the Voice Impaired) DEVICE

Speech Recognition Application for the Voice Impaired (SRAVI) is a novel communication aid developed by Liopa (a company formed by Queen's University Belfast (QUB) and the Centre for Security Information Technologies (CSIT), QUB). SRAVI is an application-based lip-reading system, and the application ('app') can be downloaded onto any device with a standard forward facing camera (e.g., smartphone, tablet). When the device is held in front of a patient, it will track lip movement and identify phrases being mouthed.

Tracheostomy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute/critical care tracheostomy patients

You may qualify if:

• Patients aged 18 years and over
• Patients who acquire a tracheostomy in acute/critical care
• Patients can move lips in a way that articulates words
• Able to communicate in English (a current requirement of the technology)

You may not qualify if:

• Patient declined consent

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Western Health and Social Care Trust: collaborator

Study Sites (1)

Wellcome-Wolfson Institute for Experimental Medicine Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

MeSH Terms

Conditions

Communication; Critical Illness

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carla McClintock
• Organization: Queen's University Belfast/Western Health & Social Care Trust

cmcclintock02@qub.ac.uk

07706482050

Study Officials

• Bronagh Blackwood, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 7, 2023
• Study Start: January 26, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 15, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)