Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-26 @ 10:04 AM
Study NCT ID:
NCT06027866
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2023-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Speech Recognition Application as a Communication Aid for Acute and Critical Care Patients With Tracheostomies
Sponsor:
Queen's University, Belfast
Organization:
Study Overview
Official Title:
A Mixed Method Prospective Observational Cohort Study to Test Speech Recognition Application for the Voice Impaired (SRAVI) as a Communication Aid for Acute and Critical Care Patients With Tracheostomies.
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SRAVI
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. Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better.
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. Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health.
The study will take place in three critical care units and one acute care unit in Northern Ireland and is expected to last 18 months. The study has been funded by the Public Health Agency Research and Development Division.
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. Using the lip-reading device in acute and critical care to test if it helps patients with tracheostomies to communicate better.
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. Follow-up with patients approximately 3-months after acute/critical care discharge to complete some further questions about their physical and mental health.
The study will take place in three critical care units and one acute care unit in Northern Ireland and is expected to last 18 months. The study has been funded by the Public Health Agency Research and Development Division.
Detailed Description:
Study Design: This is a mixed-method, multi-centre prospective observational cohort study to establish the feasibility of SRAVI. Mixed methods include:
* A multi-centre prospective observational cohort study of SRAVI as an addition to usual communication aids.
* Qualitative interviews/focus groups to inform future study design by exploring patients', their significant others and the critical care MDTs' subjective experiences of the study intervention and outcome measures.
Sample size: The investigators aim to recruit a minimum target of 55 patients. For every patient recruited, the investigators anticipate that three qualitative interviews will be undertaken (i.e., with the patient, their significant other, and at least one healthcare professional). Therefore, a feasible target recruitment is 165 participants.
Consent: Written informed consent will be obtained from participants or a personal or professional consultee in accordance with ethical approval.
Data collection: Data will be collected by the investigators and recorded in the study case report form (CRF).
Baseline data
* Inclusion/exclusion criteria and eligibility screen
* Sex
* Age on admission to hospital
* Date of acute/critical care admission
* Admission diagnosis
* Date of tracheostomy insertion during acute/critical care
Daily data collected
* CAM-ICU score (critical care patients only)
* Frequency of SRAVI delivery
* Compliance with SRAVI use
* Adverse events
Feasibility and clinical outcome data collected in acute/critical care
* Screening
* Recruitment rates
* Adverse events
* Delirium (critical care patients only)
Data collected after critical care discharge
• Duration of critical care stay
Data collected during virtual/telephone/in-person follow-up 3 months following acute/critical care discharge:
* Health related quality of life (HRQoL)
* Post-Traumatic Stress Disorder (PTSD)
* Anxiety and depression
* Cognitive status
Data analysis: Descriptive analysis will be used to analyse data from the observational cohort study. Numbers of patients screened, eligible, recruited, consented, and withdrawn from the study will be reported. Baseline demographic and clinical data will be summarised for study participants. Continuous variables will be summarised as mean (standard deviation) and median (interquartile range) and categorical variables will be summarised as number (percent).
Qualitative interviews/focus groups: Interviews/focus groups will be conducted by the investigator. Interview schedules/focus group topic guides will be developed from discussions within the research team, the patient advisory group, and from literature around study participation. The schedules will include a pre-defined list of questions that will be informed by the objectives of the study. The schedule will enable all participants to be asked similar questions and thus permit comparison of themes across each subject during data analysis.
Qualitative data collection: Interviews/focus groups will be audio recorded and professionally transcribed verbatim using an authorised transcription service. All identifying information will be removed prior to analysis. Transcriptions will be reviewed and verified prior to analysis by the research fellow by comparing the audio and written versions to identify errors.
Qualitative analysis: Qualitative data will be subjected to a thematic analysis, using Newell and Burnard's framework. This approach will permit an inductive process of drawing out important data-driven themes and a deductive process relating the major themes that emerge to the pre-defined objectives of the research. A process of constant comparison, reading, and re-reading of the data will enable identification of emerging themes. The process will be facilitated by using a computer-assisted qualitative data software package, NVIVO.
* A multi-centre prospective observational cohort study of SRAVI as an addition to usual communication aids.
* Qualitative interviews/focus groups to inform future study design by exploring patients', their significant others and the critical care MDTs' subjective experiences of the study intervention and outcome measures.
Sample size: The investigators aim to recruit a minimum target of 55 patients. For every patient recruited, the investigators anticipate that three qualitative interviews will be undertaken (i.e., with the patient, their significant other, and at least one healthcare professional). Therefore, a feasible target recruitment is 165 participants.
Consent: Written informed consent will be obtained from participants or a personal or professional consultee in accordance with ethical approval.
Data collection: Data will be collected by the investigators and recorded in the study case report form (CRF).
Baseline data
* Inclusion/exclusion criteria and eligibility screen
* Sex
* Age on admission to hospital
* Date of acute/critical care admission
* Admission diagnosis
* Date of tracheostomy insertion during acute/critical care
Daily data collected
* CAM-ICU score (critical care patients only)
* Frequency of SRAVI delivery
* Compliance with SRAVI use
* Adverse events
Feasibility and clinical outcome data collected in acute/critical care
* Screening
* Recruitment rates
* Adverse events
* Delirium (critical care patients only)
Data collected after critical care discharge
• Duration of critical care stay
Data collected during virtual/telephone/in-person follow-up 3 months following acute/critical care discharge:
* Health related quality of life (HRQoL)
* Post-Traumatic Stress Disorder (PTSD)
* Anxiety and depression
* Cognitive status
Data analysis: Descriptive analysis will be used to analyse data from the observational cohort study. Numbers of patients screened, eligible, recruited, consented, and withdrawn from the study will be reported. Baseline demographic and clinical data will be summarised for study participants. Continuous variables will be summarised as mean (standard deviation) and median (interquartile range) and categorical variables will be summarised as number (percent).
Qualitative interviews/focus groups: Interviews/focus groups will be conducted by the investigator. Interview schedules/focus group topic guides will be developed from discussions within the research team, the patient advisory group, and from literature around study participation. The schedules will include a pre-defined list of questions that will be informed by the objectives of the study. The schedule will enable all participants to be asked similar questions and thus permit comparison of themes across each subject during data analysis.
Qualitative data collection: Interviews/focus groups will be audio recorded and professionally transcribed verbatim using an authorised transcription service. All identifying information will be removed prior to analysis. Transcriptions will be reviewed and verified prior to analysis by the research fellow by comparing the audio and written versions to identify errors.
Qualitative analysis: Qualitative data will be subjected to a thematic analysis, using Newell and Burnard's framework. This approach will permit an inductive process of drawing out important data-driven themes and a deductive process relating the major themes that emerge to the pre-defined objectives of the research. A process of constant comparison, reading, and re-reading of the data will enable identification of emerging themes. The process will be facilitated by using a computer-assisted qualitative data software package, NVIVO.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: