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.
Conditions: Tracheostomy, Communication, Acute/Critical Illness
Sponsor: Queen's University, Belfast

 
A speech recognition application as a communication aid for acute and critical 
care patients with tracheostomies 
NCT06027866 
06.10.2023 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol number: 
B22/04 
Protocol version: 
 
V5.0 
Protocol date: 
06.10.2023 
IRAS Number 
307199 
Sponsor Number 
B22/04 
Funder 
Public Health Agency  
Northern Ireland 
Research and Development Division 
Primary Sponsor 
Queen’s University Belfast  
Ethics Reference Number 
22/NI/0109 
 
Chief Investigator: 
Prof Bronagh Blackwood 
Wellcome-Wolfson Institute for 
Experimental Medicine 
Queen’s University Belfast 
97 Lisburn Road 
BT9 7BL 

 
 
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TABLE OF CONTENTS 
 
GLOSSARY OF ABBREVIATIONS…………………………………………………………………...........3 
PROTOCOL SUMMARY……………………………………………………………….…………………....................................4 
STUDY TEAM……………………………………………………………………………………………………………………………………6 
1. BACKGROUND AND RATIONALE………………………………………………………...……………7 
1.1 BACKGROUND INFORMATION..…………………………………………………………………………………………....7 
    1.2 RATIONALE FOR STUDY…………………………………………………………………………..................................8 
    1.3 RATIONALE FOR INTERVENTION……………………………………………………………….............................10 
2. RESEARCH AIM AND OBJECTIVES……………………………………………………...…………..11 
    2.1 RESEARCH AIM………………………………………………………………………………………11 
    2.2 RESEARCH OBJECTIVES…………………………………………………………………………..12 
3. STUDY DESIGN AND SETTING…………………………………………………………………..........12 
    3.1 STUDY DESIGN………………………………………………………………………………………12 
    3.2 STUDY SETTING…………………………………………………………………………................12 
    3.3 SAMPLE SIZE…………………………………………………………………………………………12 
    3.4 DURATION OF STUDY………………………………………………………………….…………...13 
    3.5 STUDY SCHEMATIC DIAGRAM……………………………………………………………………14 
    3.6 PRIMARY OUTCOME MEASURES…………………………………………………….................14 
    3.7 SECONDARY OUTCOME MEASURES……………………………………………...….………...15 
    3.8 STUDY INTERVENTION…………………………………………………………………................15 
4. SCREENING, RECRUITMENT AND CONSENT……………………………………………………...17 
    4.1 ELIGIBILITY CRITERIA………………………………………………………………………………17 
          4.1.1 INCLUSION CRITERIA…………………………………………………………….................17 
          4.1.2 EXCLUSION CRITERIA…………………………………………………………………….....17 
    4.2 RECRUITMENT AND SCREENING PROCEDURE………………………………………………17 
    4.3 CONSENT………………………………………………………………………………….................17 
          4.3.1 INFORMED CONSENT PROCEDURE………………………………………………………17 
          4.3.2 INFORMED ADVICE FROM PERSONAL CONSULTEE………………………………….18 
          4.3.3 APPROVAL BY A PROFESSIONAL CONSULTEE…………………………….................19 
          4.3.4 INFORMED PARTICIPANT CONSENT FOLLOWING RECOVERED  
                   MENTAL CAPACITY…………………………………………………………………………...19 
          4.3.5 INFORMED CONSENT (PATIENTS WITH CAPACITY (ACUTE CARE- TOTAL  
                   LARNYGECTOMY)………………………………..............................................................20 
          4.3.6 INFORMED CONSENT (PATIENTS WITH CAPACITY (ACUTE CARE-  
                   TRACHEOSTOMY)…………………………………………………………………………….20 
    4.4 DETAIL OF INTERVENTION…………………………………………………………….................21 
5. DATA COLLECTION AND MANAGEMENT……………………………………………….................21   
    5.1 DATA VARIABLES……………………………………………………………………………………22 
          5.1.1 BASELINE DATA DATA…………………………………………………………...................22 
          5.1.2 DAILY DATA COLLECTION………………………………………………………................23 
          5.1.3 FEASIBILITY & CLINICAL OUTCOME DATA COLLECTED IN ACUTE & 
                   CRITICAL CARE…………………………………………………………………. ……………23 
          5.1.4 DATA COLLECTED AFTER CRITICAL CARE DISCHARGE……………………………..23 
    5.2 QUANTITATIVE STUDY INSTRUMENTS………………………………………………………….23 
    5.3 QUANTITATIVE DATA ANALYSIS………………………………………………………………….24 
6. WITHDRAWAL FROM STUDY………………………………………………………………................25 
7. QUALITATIVE INTERVIEWS………………………………………………………………….………...25 
    7.1 PROCESS…………………………………………………………………………………….………..25 

 
 
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          7.1.1 PATIENTS AND/OR SIGNIFICANT OTHERS……………………………………..………..25 
          7.1.2 ACUTE & CRITICAL CARE MDT MEMBERS……………………………………..………..26 
    7.2 CONSENT…………………………………………………………………………………………......26 
          7.2.1 PATIENTS AND/OR SIGNIFICANT OTHERS………………………………………………26 
          7.2.2 ACUTE & CRITICAL CARE MDT MEMBERS……………………………………...............27 
    7.3 QUALITATIVE DATA COLLECTION……………………………………………………….……….27 
    7.4 QUALITATIVE DATA ANALYSIS…………………………………………………………..............27 
8. SAFETY REPORTING…………………………………………………………………………...............28 
    8.1 DEFINITIONS………………………………………………………………………………...............28 
          8.1.1 ADVERSE EVENTS……………………………………………………………….………......28 
          8.1.2 ADVERSE DEVICE EFFECTS…………………………………………………………….....29 
          8.1.3 SERIOUS ADVERSE EVENTS……………………………………………………...............29 
           8.1.4 SERIOUS DEVICE EFFECTS………………………………………………………………..29 
           8.1.5 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECTS……………………………30 
    8.2 ASSESSMENT OF CAUSALITY…………………………………………………………………….30 
    8.3 REPORTING AND RECORDING…………………………………………………………………...30 
9. END OF STUDY…………………………………………………………………………………………...31 
10. ETHICAL AND REGULATORY CONSIDERATIONS……………………………………................32 
     10.1 ACCESS TO STUDY DATA……………………………………………………………................32 
     10.2 STUDY COMMITTEES…………………………………………………………………................32 
            10.2.1 STUDY MANAGEMENT GROUP………………………………………………………….32 
            10.2.2 PATIENT ADVISORY GROUP…………………………………………………................33 
            10.3 SPONSORSHIP………………………………………………………………………………..33 
     10.4 FUNDING…………………………………………………………………………………...............33 
     10.5 CONTRIBUTORSHIP………………………………………………………………….…………...33 
     10.6 PATIENT AND PUBLIC INVOLVEMENT………………………………………………………...34 
     10.7 COMPETING INTERESTS………………………………………………………………………...34 
     10.8 INDEMNITY………………………………………………………………………………...............34 
     10.9 STUDY PROTOCOL………………………………………………………………………………..34 
           10.9.1 PROTOCOL AMENDMENTS……………………………………………………………….34 
           10.9.2 PATIENT CONFIDENTIALITY……………………………………………………………...35 
11. DISSEMINATION POLICY……………………………………………………………………………...35 
      11.1 STUDY RESULTS………………………………………………………………………...............35 
      11.2 AUTHORS…………………………………………………………………………………………..36 
REFERENCES………………………………………………………………………………………………..37 

 
 
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GLOSSARY OF ABBREVIATIONS 
Abbreviation / Acronym 
Full Wording 
AAC 
Augmentative and Alternative 
Communication 
ACV 
Above Cuff Vocalisation 
AI 
Artificial Intelligence  
BACCN 
British Association of Critical Care Nurses 
BHSCT 
Belfast Health and Social Care Trust 
CAM-ICU 
Confusion Assessment Method in the 
Intensive Care Unit   
CI 
Chief Investigator 
CORE-Q 
Consolidated Criteria for Reporting 
Qualitative Research 
CSIT 
Centre for Secure Information 
Technologies 
GCP 
Good Clinical Practice 
HADS 
Hospital Anxiety and Depression Scale 
HRQoL 
Health Related Quality of Life 
IES-R 
Impact of Events Scale (Revised)  
MDT 
Multidisciplinary team 
MoCA-BLIND 
Montreal Cognitive Assessment-BLIND 
NI 
Northern Ireland 
NICE 
National Institute for Health and Care 
Excellence 
PHA 
Public Health Agency 
PI 
Principal Investigator 
PPI 
Patient and Public Involvement 
PTSD 
Post-Traumatic Stress Disorder 
QUB 
Queen’s University Belfast 
REC 
Research Ethics Committee 
SRAVI 
Speech Recognition Application for Voice 
Impaired  
UKGDPR 
UK General Data Protection Regulation 
VSR 
Visual Speech Recognition 
WHSCT 
Western Health and Social Care Trust  
 

 
 
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PROTOCOL SUMMARY 
Protocol 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. 
 
Health 
condition(s) or 
problem(s) 
studied 
Adults admitted to acute or critical care units with a tracheostomy. 
 
Study design 
Multi-site, prospective observational cohort study. 
 
Study Aim and 
Objectives 
Aim: To establish the feasibility and acceptability of implementing 
Speech Recognition Application for the Voice Impaired (SRAVI) for 
acute and critical care patients with a tracheostomy who are unable to 
communicate using verbal speech. 
 
Objectives:  
1. To evaluate patients’ capability in using SRAVI and barriers to 
its use. 
2. To measure accuracy of SRAVI. 
3. To explore the experience of patients, their significant others, 
and acute and critical care multidisciplinary team (MDT) 
members with and without the use of SRAVI.  
4. To assess recruitment and collection of clinical outcomes. 
 
Study 
Intervention 
Speech Recognition Application for the Voice Impaired (SRAVI)  
Comparator 
None 
 
Primary outcome 
1. Patient capability to use SRAVI  
2. User acceptability of the intervention 
 
Secondary 
outcomes 
1. Feasibility of collection of clinical data measures: 
a. Duration of critical care length of stay 
b. Duration of hospital length of stay 
c. Delirium occurrence during critical care stay 
d. Health Related Quality of Life (HRQoL) 
e. Anxiety and depression 
f. Post-Traumatic Stress Disorder (PTSD) 
g. Cognitive status 
2. Estimation of recruitment and retention to inform design of a 
clinical trial. 
3. Identification of additional important outcomes reported by 
patients, relatives, and healthcare professionals. 
 
 
Key inclusion 
and exclusion 
criteria 
Patient inclusion criteria: 
1. Patients aged 18 years and over 
2. Patients who acquire a tracheostomy in acute or critical care 

 
 
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3. Patients can move lips in a way that articulates words 
4. Able to communicate in English (a current requirement of the 
technology) 
 
Patient exclusion criteria: 
1. Patient declined consent 
 
Study setting 
Three critical care units in Northern Ireland: Royal Victoria Hospital 
(RVH), Belfast; City Hospital, Belfast and Altnagelvin Hospital, Derry 
and a regional head and neck centre, RVH Belfast. 
 
Sample size  
A minimum target of 55 patients. 
 
Study Duration 
18 months  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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STUDY TEAM 
Chief Investigator 
Professor Bronagh Blackwood 
Wellcome-Wolfson Institute for Experimental 
Medicine, Queen’s University Belfast (QUB) 
Co-investigators 
Carla McClintock (Research Fellow) 
Wellcome-Wolfson Institute for Experimental 
Medicine, QUB & Western Health and Social 
Care Trust (WHSCT) (Altnagelvin Hospital) 
 
Professor Daniel McAuley  
Wellcome-Wolfson Institute for Experimental 
Medicine, QUB & Belfast Health and Social 
Care Trust (BHSCT) 
 
Dr Bronwen Connolly 
Wellcome-Wolfson Institute for Experimental 
Medicine, QUB 
 
Dr Jon Silversides 
Wellcome-Wolfson Institute for Experimental 
Medicine, QUB, Belfast & BHSCT 
 
Sallyanne Duncan 
Wellcome-Wolfson Institute for Experimental 
Medicine, QUB & BHSCT 
 
Dr Shondipon Laha 
Lancashire Teaching Hospital NHS 
Foundation Trust 
 
Dr Jacqueline Twamley 
Lancashire Teaching Hospital NHS 
Foundation Trust 
 
Professor Louise Rose  
Kings College London 
 
Mr Mark Adams 
Regional Head and Neck Centre, Royal 
Victoria Hospital Belfast 
 
Richard McConnell 
Liopa Ltd., Belfast 
 
Chantal Davies 
PPI Representative 
Study Sponsor  
Queen’s University Belfast  
 
 
 
 
 
 
 
 
 

 
 
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1. 
BACKGROUND AND RATIONALE 
1.1 
Background Information 
Voice represents one of the most fundamental components of human 
communication.  Yet when patients are admitted to hospital their ability to effectively 
communicate may be temporarily or permanently compromised by the nature of their 
illness and treatment. 
 
Critical Care  
In the UK, approximately 10,000 patients annually undergo a tracheostomy (1).  A 
paradigm shift in critical care management towards lighter sedation in mechanically 
ventilated patients has increased the number of patients potentially able to 
communicate while awake (2). An advantage of tracheostomy is that patients can 
have reductions or cessation of sedative medication but may find themselves in a 
situation where they are alert, yet still reliant on positive pressure ventilator support. 
This almost universally requires an inflated tracheostomy tube cuff to deliver the 
pressure generated by the ventilator to the lungs.  For the majority of these patients 
who remain significantly ventilator-dependent or have a considerable aspiration risk 
that inhibits cuff deflation, the continued presence of the inflated cuff by necessity 
‘seals off’ the upper airway, preventing effective oral communication (3).  
 
The impact of altered communication function has been described as one of the 
most stressful events of critical care admission (4) and the presence of a 
tracheostomy tube with an inflated cuff significantly impacts upon an individual’s 
ability to effectively communicate, interact, and participate within the healthcare 
system (5).  Nearly two-thirds of ventilated patients report communication as difficult, 
and this contributes to negative emotions during critical care (6,7).  Patients report 
loss of voice leading directly to frustration (8), panic (9), anger (10), fear (11), a 
sense of depersonalisation, powerlessness, and a sense of futility (12, 13). 
Importantly emotional distress experienced during critical care is a predictor of 
negative psychological outcomes during recovery.  Anxiety (14, 15), depression (16, 
17), PTSD (18, 19) and intrusive and delusional memories (20, 21) have been 
reported as frequent sequelae for many critical care survivors. Delirium, a form of 
acute brain dysfunction that is common during critical illness, has consistently been 

 
 
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shown to be associated with long-term cognitive impairment. Impaired 
communication may contribute to delirium. Cognitive dysfunction following critical 
care discharge has been demonstrated in up to 66% of survivors, with impairments 
documented in one-third up to six years after hospital discharge (22).  
 
Acute Care  
In the UK approximately 12,400 new cases of head and neck cancer are diagnosed 
annually.  Accounting for 3% of all new cancer cases, it is the 8th most common 
cancer in the UK (23).  For some patients with laryngeal carcinoma, total 
laryngectomy is a treatment option (24). This surgical procedure involves the 
disconnection of the airway following removal of laryngeal structures and part of the 
upper trachea. Although an effective cancer treatment, the resulting permanent 
tracheostomy is at the expense of the patient’s natural voice (25).   Whilst many 
patients adapt well to new forms of communication, some experience considerable 
psychosocial burden.  Greater levels of depression and anxiety have been reported 
in 30% of TL patients (26). Loss of natural voice is also associated with decreased 
social activity with an estimated 40% of patients experiencing social withdrawal (27). 
 
In addition to laryngectomy (a planned procedure resulting in a permanent 
tracheostomy), various scenarios in the acute care setting may necessitate a 
temporary tracheostomy. Reasons may include upper airway obstruction resulting 
from conditions such as vocal cord paralysis, tracheal or laryngeal stenosis, 
infection, or trauma. A tracheostomy establishes an alternative pathway for air to 
bypass the upper airway, thereby facilitating its passage into the lungs. 
 
1.2 
Rationale for the study 
Augmentative and Alternative Communication (AAC) strategies describe a wide 
spectrum of tools, technologies, and/or approaches used to solve communicative 
challenges in patients who are unable to communicate through verbal speech (28).   
 
Critical Care 
AAC is not always effective in the critical care setting as strategies for voiceless 
patients are often too complex for this population. Critical illness neuropathy and 

 
 
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altered cognitive functioning often mean that patients lack the manual dexterity to 
use such aids (29). Low-tech communication aids including pen and paper and 
communication boards have been described as tedious, limited, and slow (30) whilst 
high-tech aids such as eye-gazing systems use bespoke hardware and require 
significant patient learning (31).  Although one-way speaking valves have been 
successfully used to restore audible and meaningful speech in patients after 
tracheostomy placement (32-33), criteria for selection of candidates for use includes 
the ability to tolerate tracheostomy cuff deflation.  Above Cuff Vocalisation (ACV) 
may be helpful for those patients who cannot tolerate cuff deflation as this technique 
uses the subglottic suction port of the tracheostomy tube to deliver a low flow of air 
or oxygen backwards up the port to exit above the cuff (34).  Gas flow can then 
travel upwards through the trachea, pass through the vocal cords, and exit via the 
mouth, resulting in audible vocalisation. However, this is a relatively new technique 
with numerous contraindications and requires further research (35). There is a need 
to develop more effective AAC strategies for critical care patients. 
 
Unaided modalities such as silent articulation of speech, gesturing, and body 
language remain the primary mode of communication used by critical care 
tracheostomy patients despite evidence showing that they are frustrating, 
insufficient, and characterised by patients not being understood (36-37). The inability 
to accurately interpret what patients are trying to say also frequently results in staff 
experiencing feelings of incompetence and despair (38-39).  Studies have described 
typical communication between patients and healthcare professionals as brief and 
targeting primarily basic medical needs due to the difficulty in understanding what 
the patient wishes to say (40).  Critical care patients describe their needs as multi-
dimensional (41) and have highlighted the need for easy to use and intuitive 
communication aids (42-43).  Impaired communication can prevent non-vocal 
tracheostomy patients from not only expressing their needs and symptoms but also 
emotions, and from participating in decisions regarding their own treatment (44).  
The integration of reliable communication interventions at the bedside is essential to 
decreasing the challenges and vulnerabilities experienced by critical care patients 
recovering from events resulting in sudden speechlessness. 
 
Acute Care 

 
 
10 
 
Whilst recent years has seen significant advances in voice restoration techniques 
following total laryngectomy, in the immediate postoperative period, low-tech 
strategies including writing and communication boards are frequently utilised. 
Alternative options such as oesophageal speech or electrolarynx speech are often 
difficult to learn effectively (45).  Tracheo-Esophageal Speech (TE-speech), a voice 
prosthesis, may also be utilised but successful TE-speech is not guaranteed with 
outcomes in voice quality and intelligibility differing between patients (46).  
 
For patients in acute care undergoing emergency tracheostomy, communication 
strategies closely resemble those used in critical care settings and the immediate 
postoperative period for total laryngectomy patients.  
 
1.3 
Rationale for the intervention 
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 (Figure 1).  
 
 
 
Figure 1: SRAVI application (47) 
 
SRAVI has been in trial by the Lancashire Teaching Hospitals NHS Foundation Trust 
since 2019.  The phase 1 trial included 15 patients who had lost their ability to speak 
from having tracheostomies and 33 critical care staff members (48).  During this initial 
phase, rapid cycles of testing confirmed that SRAVI can be used to communicate from 
a list of the most common and important phases as identified by patients and staff with 

 
 
11 
 
good accuracy.  As SRAVI is based upon artificial intelligence (AI) algorithms, it was 
important to determine that the app will read the patients’ lips better as they continue 
using it.  Critically, Phase I proved that SRAVI returns the correct phrase that has been 
lip-read with greater than 90% accuracy. The recognition system is able to discern the 
correct phrase in the top 3 with 100% accuracy. The longer the patients used SRAVI, 
the better the app became at interpreting what they were saying (Figure 2).   
 
 
Figure 2: Accuracy and SRAVI engagement (49) 
 
Compared to the limited alternatives available, SRAVI potentially could provide an 
easier, more accurate, and cost-effective method for communication between 
tracheostomy patients, healthcare professionals, and relatives. 
  
2. 
RESEARCH AIM AND OBJECTIVES 
2.1  
Research Aim 
The overarching aim of this research is to establish the feasibility and acceptability of 
SRAVI for adult acute and critical care patients with a tracheostomy who are unable 
to communicate using verbal speech. 

 
 
12 
 
 
2.2 
Research Objectives 
1. To evaluate patients’ capability in using SRAVI and barriers to its use. 
2. To measure accuracy of SRAVI. 
3. To explore the experience of patients, their significant others, and acute and 
critical care multidisciplinary team (MDT) members with and without the use of 
SRAVI.  
4. To assess recruitment and collection of clinical outcomes. 
 
3. 
STUDY DESIGN AND SETTING 
3.1 
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 to inform future study design by exploring patients’, their 
significant others and the acute and critical care MDTs’ subjective experiences of 
the study intervention and outcome measures.  
 
3.2 
Study Setting 
The study will be conducted at four sites: the 32- bed regional critical care unit based 
at the Royal Victoria Hospital (RVH), Belfast, NI; the 10- bed general critical care unit 
based at the City Hospital, Belfast, the 10-bed general critical care unit based at 
Altnagelvin Hospital, Derry, NI and a regional head and neck centre based at RVH 
Belfast  
 
3.3 
Sample Size 
The sample size is based on previous critical care feasibility studies showing a 
participation rate of 50%. Due to the onset of the SARS-CoV-2 pandemic, the role and 
timing of tracheostomy for patients requiring critical care for coronavirus disease 
(COVID-19) remains unclear (50). To circumvent this, pre-COVID19 local audit data 
has been used to estimate sample size.  In 2019, an average of 70 tracheostomies 
were completed in Royal Victoria Hospital, Belfast, 20 in City Hospital, Belfast and 20 

 
 
13 
 
in Altnagelvin Hospital, Derry. We aim to recruit as many patients as possible but 
aiming for a minimum target of 55 patients.  
 
For every patient recruited to the prospective observational cohort study, we will aim 
to undertake two interviews as part of the qualitative component of the study (i.e., the 
patient and their significant other). We will also aim to host a minimum of five staff 
focus groups and will include a representative sample of medical, nursing and allied 
healthcare professionals of various grades with no more than eight participants per 
session.  
 
Therefore, a feasible target recruitment is 150 participants. However, in keeping with 
the principles of rigorous qualitative research we will be responsive to the study 
context and anticipate that in some cases fewer interviews/focus groups will be 
conducted and in others, additional interviews/focus groups will be conducted to 
achieve data saturation.   
 
3.4 
Duration of study 
The proposed study duration is 18 months.  
• Recruitment phase: patient recruitment is estimated to take 14 months. 
• Treatment phase: SRAVI in addition to usual communication aids will be used 
for the duration of the patient’s acute or critical care stay. 
• Follow-up phase: 3 months after acute or critical care discharge. 
• End of study: is defined as the last 3-month observation of the last patient in 
the follow-up phase of the study and is anticipated to be 17 months after 
recruitment of the first patient. 
 
 
 
 
 
 
 
 

 
 
14 
 
3.5 
 
Study schematic diagram 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.6 
Primary Outcome Measure 
1. Capability of patients to use SRAVI as defined by: 
• Measurement of frequency of use. 
• Measurement of words correctly captured. 
• Measurement of frequency of patients who could not use SRAVI and 
reverted to other communication aids. 
2. Acceptability of SRAVI as a communication aid as expressed in qualitative 
interviews with patients, family and the MDT. 
 
Adult critical care tracheostomised patients (n=) 
Adult acute care tracheostomised patients  (n=) 
Assessed for eligibility (n=) 
Not assessed for eligibility (n=) 
Excluded (n=) 
Ineligible (n=) 
Eligible but not recruited (n=) 
Total recruited (n=) 
Lost to follow-up (n=) 
Follow-up at 3 months post-discharge from acute 
or critical care facility (n=) 
Data Analysis (n=) 

 
 
15 
 
3.7 
 Secondary Outcome Measures 
1. Enrolment: the ability to identify eligible patients over the study period. 
2. Consent: the number of patients consenting to be included as a proportion of 
all patients approached about the study, with reasons for non-consent. 
3. Retention and dropout rates: 
• Number of patients who commence the intervention as a proportion of the 
number recruited, with reasons for non-compliance. 
• Number of patients who continue the intervention as a proportion of the 
number recruited, with reasons for non-continuation. 
• Qualitative assessment of barriers/facilitators to data collection and 
participant retention 
 
4. Data collection of outcome measures: 
I. 
Duration of critical care length of stay 
II. 
Duration of hospital length of stay 
III. 
Delirium occurrence during critical care stay (delirium positive on CAM-
ICU) 
IV. 
Clinical outcomes at 3-months post-critical care discharge 
a. Health related Quality of Life measured by the European Quality 
of Life-5 Dimensions (EQoL-5D)  
b. Anxiety and depression measured by the Hospital Anxiety and 
Depression Scale (HADS).  
c. Posttraumatic stress measures by the Impact of Events Scale-
Revised (IES-R).  
d. Cognitive status measured by the Montreal Cognitive 
Assessment-BLIND (MOCA-BLIND). 
5. Identification of additional important outcomes (by qualitative interviews). 
 
3.8 
Study Intervention 
All consenting participants will receive access to SRAVI, 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 

 
 
16 
 
products Regulatory Agency (MHRA) and CE marked for intended use.  SRAVI is 
based on LipRead, Liopa’s Visual Speech Recognition (VSR) platform.  Specifically, 
the LipRead technology can determine speech by analysing the movements of a 
user’s lips as they speak into a camera.  These lip movements are known as 
visemes and are the visual equivalent of a phoneme or unit of sound in spoken 
language. 
 
A flow chart showing how the video data is passed through the system is shown in 
Figure 3.  Using the device camera, SRAVI records a video of the patient mouthing a 
phrase. The patient’s ID is entered by the device user.  The video file is stored in an 
archive with restricted access.  A record of users and phrases is stored anonymously 
in a database.  This video is sent to a secure server with data encrypted at rest and 
during transit, meaning that the data cannot be viewed by any third parties.  Video 
clips will be retained for the lifetime of the study to enable Liopa to improve the 
system over time and to run all data through at the conclusion of the study to provide 
updated accuracy results. Once the video reaches the server, LipRead technology 
detects and tracks the lip movements and converts those into text on the device 
screen within a few seconds (Figure 3).  SRAVI can adapt to an individual’s lip 
movements over time, which means it becomes increasingly accurate the more it is 
used.  
 
 
Figure 3: How SRAVI works (51) 
 
 

 
 
17 
 
4. 
Screening, recruitment, and consent 
4.1 
Eligibility Criteria 
All patients admitted to the acute and critical care facilities during the study period 
and fulfilling the following inclusion criteria will be eligible. 
 
4.1.1 Inclusion Criteria 
• Patients aged 18 years and over at the time of screening 
• Have a tracheostomy in-situ that was inserted during current acute or critical 
care admission 
• Able to communicate in English (a current requirement of the technology) 
• Able to move lips in a way that articulates words 
 
4.1.2 Exclusion Criteria 
• Patient declined consent 
 
4.2 
Recruitment and Screening Procedure 
The research fellow will consult members of the acute and critical care team at each 
study site daily to establish the eligibility of acute and critical care tracheotomised 
patients.  All patients who meet all the inclusion criteria and none of the exclusion 
criteria will be eligible for inclusion in data analysis.  Authorised nursing/medical staff 
on the delegation log will confirm eligibility. A screening log will be maintained that 
will include details of the number of participants excluded and the reason for 
exclusion.  
 
4.3 
Consent 
4.3.1 Informed Consent Procedure 
It is the responsibility of the Principal Investigator (PI) (or designee) to ensure that 
written informed consent is obtained for each participant prior to entry into the 
prospective observational cohort study. Consent may be obtained by the PI or an 
appropriately trained member of the research team. The PI (or designee) taking 
informed consent must be Good Clinical Practice (GCP) trained, suitably qualified 
and experienced and have been delegated this duty by the PI on the delegation log.  

 
 
18 
 
Where patients’ representatives require further clarification about the benefits and 
risks of participating, this will be provided by the research team.  
 
Critical Care   
4.3.2 Informed Advice from Personal Consultee  
Patients in critical care are typically incapacitated by the nature of their critical illness 
such that they are typically unable to give informed consent for participation 
themselves.  The Northern Ireland Mental Capacity Act (52) states that family 
members or next of kin must be involved in the process of providing advice where 
their next of kin lacks mental capacity at the time of study recruitment.  Once a 
potential participant has been screened for inclusion, a member of the research team 
will seek advice from a personal consultee (who may be a relative, partner or friend 
of the participant).  This will normally take place during a face-to face meeting. A 
research team member will describe the study to the individual, and provide them 
with a Covering Statement, Information Sheet and Personal Consultee Declaration.  
The researcher will seek their views about whether the patient should take part in the 
study. They will be asked about their opinion of the wishes and feelings of the patient 
if they had capacity. 
 
After the researcher has checked that the information sheet is understood, the 
researcher will invite the personal consultee to sign the form and will then 
countersign it.  A copy of the form will be placed in the patient’s medical notes, a 
copy given to the personal consultee and the original filed in the study site file. 
(CRF).  
 
If the personal consultee is not available at site, the researcher may contact the 
personal consultee by telephone and seek verbal agreement.  This verbal agreement 
will be recorded in the Consultee Telephone Agreement Form.  The Consultee 
Telephone Agreement Form will be signed by a second member of staff who 
witnessed the telephone advice.  This witness may be a member of the site study 
team or member of the critical care team.  A copy of the Consultee Telephone 
Agreement Form will be placed in the patient’s medical notes and the original filed in 

 
 
19 
 
the CRF.  Written agreement will be obtained as soon as possible and if this is not 
obtained, a patient will not be recruited into this study. 
 
4.3.3 Approval by a Professional Consultee 
In the event that there is no personal consultee, authorisation to recruit the patient 
will be sought from a professional consultee (a doctor unrelated to the research 
study team). The professional consultee will be informed about the study by a 
member of the research team and given a copy of the Professional Consultee Form 
and a copy of the Covering Statement, Consultee Information Sheet and Consultee 
Declaration.  If the professional consultee decides that the patient is suitable for 
entry into the study, they will be asked to complete the relevant authorisation form.  
A copy of the authorisation form will be placed in the patient’s medical notes and the 
original filed in the study site file. In the event that a personal consultee is identified 
after professional consultee advice is obtained, the above process for Informed 
Advice from Personal Consultee will be followed and all advice forms will be filed as 
instructed above. 
 
4.3.4 Informed Participant Consent following recovered mental capacity 
If a patient regains capacity to consent, they will be approached by the research 
fellow who will give them background information on the study and will explain who 
gave agreement for them to participate in the study. The consent to continue process 
will include: assessment and documentation of capacity; providing the Patient 
Information Sheet and Consent Form for Participant with Recovered Capacity; 
allowing sufficient time for the patient to understand the material and ask questions; 
obtaining written informed consent. If the patient agrees to continue in the study, 
they will be asked to sign the Consent Form for Participant with Recovered Capacity 
Form which will then be counter signed by a member of the research team. The 
original copy of the Participant with Recovered Capacity Form will be filed in the 
study site file, a copy filed in the patient’s medical notes and a copy provided to the 
patient.  
 
If the patient refuses consent, the patient will be asked to specify whether they will 
allow data collected so far to be entered into the analysis. In the situation that the 

 
 
20 
 
patient does not consent to any data collected to be used, no data will be entered 
into the analysis and no further data will be collected.  Any video files collected will 
be deleted. In the rare event that the patient does not regain capacity to consent, 
analysis will proceed based on the MDT decision to include the patient in the study 
based on an assessment that it is in the patient’s best interest. Participants will be 
contacted by the research fellow three months’ post-critical care discharge to collect 
long term outcomes. The research fellow will conduct these either face-to-face, 
virtually or by telephone. Three months has been deemed appropriate as National 
Institute for Health and Care Excellence (NICE) (53) guidelines advocate a review of 
patients at this stage to determine the extent of their recovery.  Research also 
indicates that patients will have gained a certain distance from the acute event 
causing critical illness and therefore it is easier for them to discuss their ICU 
experience (54-55).  If the participant declines on-going participation in the study, no 
further follow-up will take place.  
 
4.3.5 Informed Consent- Patients with Capacity (Acute Care- Total 
Laryngectomy )  
The study will be discussed with potential participants during their face-to-face 
preoperative assessment appointment at the outpatient clinic. A member of the 
research team or a GCP trained member of the clinical team will provide potential 
participants with a participant information sheet. Upon admission to hospital for 
surgery, a member of the research team or GCP trained clinical team member will 
ask patients’ views on if they wish to participate in the study and answer any 
questions they may have.  Should they agree to participate in the study, written 
informed consent will be obtained.  
  
4.3.6 Informed Consent- Patients with Capacity (Acute care-Tracheostomy)  
Once a potential participant has been screened for inclusion, a member of the 
research team will approach the patient where they will describe the study to the 
individual and provide them with a Participant Information Sheet.  The researcher will 
seek their views about whether they wish to participate in the study. This will 
normally take place during a face-to face meeting.  After the researcher has checked 
that the information sheet is understood, the researcher will invite the patient to sign 
the consent form and will then countersign it.  A copy of the form will be placed in the 

 
 
21 
 
patient’s medical notes, a copy given to the patient and the original filed in the study 
site file. (CRF).  
 
4.4 
Detail of Intervention 
Following personal or professional consultee advice or informed consent, a patient 
will be entered into the research study as a participant. Participants will have access 
to SRAVI ideally on the day they are recruited or within 24 hours of recruitment. Staff 
will be instructed to offer SRAVI as the first choice of communication aid.  This will 
not preclude participants from using other communication aids normally used in the 
acute or critical care unit, e.g., communication boards, pen and paper, gesturing, 
head nods and speaking valves. The SRAVI app will automatically capture frequency 
of use. 
TIDieR item  
Descriptor 
Item 
1 
Brief name 
A speech recognition app delivered in acute and critical care to tracheostomised 
patients.  
2 
Why 
To facilitate communication in tracheostomised critical care patients 
3 
What materials 
• 
Tablets/smartphones 
• 
SRAVI app 
4 
What 
procedures 
SRAVI is held in front of a patient to track their lip movements and identify 
phrases being mouthed.  If the patient is assessed to be well enough, they may 
hold the device themselves. A video of the patient’s face is captured by the 
device camera and sent to the VSR engine for processing.  The phrase being 
spoken is identified from a pre-defined list and translated to text on the device 
screen.  
5 
Who provides 
Acute and critical care healthcare professionals (and potentially patient and 
carers) will provide the intervention and will be appropriately trained to use the 
intervention.  
6 
How 
Face to face at patient’s bedside in acute and critical care 
7 
Where 
Three critical care unit in NI: Royal Victoria Hospital, Belfast, City Hospital, 
Belfast and Altnagelvin Hospital, Derry and a regional head and neck centre, 
RVH, Belfast. 
8 
When and how 
much 
Patients will have continued access to SRAVI from the day they are recruited 
into the study up until they no longer require the app (or discharge from the 
acute or critical care facility) 
9 
Tailoring 
Not applicable 
10 
How well 
Not applicable  
 
Table 1: Intervention description using the Template for Intervention Description and Replication 
(TIDieR) checklist (56). 
 
 
5. 
Data Collection and Management 
Data collection will be restricted to variables required to define patient characteristics 
at enrolment; to monitor the use of SRAVI and other communication aids and record 
any adverse events; to record feasibility and clinical outcomes of this study. All 
patient data will be collected by the research fellow and recorded on study-specific 
paper proformas initially at patient’s bedside.  Information on paper copies will be 

 
 
22 
 
transferred to an identical electronic version of these proformas and stored into the 
study database at QUB.  Patient identification on any study-specific proformas will be 
through their unique trial identifier, allocated to them at the time of recruitment.   
 
All documentation and study records will be stored securely according to applicable 
legislation and regulatory standards.  Access to stored information will be restricted 
to authorised personnel (i.e., research fellow and academic supervisors).  Study 
documentation and data will be archived after completion of the study in keeping with 
the applicable regulatory requirements. 
Video files captured by the SRAVI app will be stored by Liopa Ltd. in an archive with 
restricted access.  Data will be encrypted at rest and during transit meaning that data 
cannot be viewed by a third party.  A record of users and phrases will be stored 
anonymously in a database that will only be accessible to the research team.  
Written informed consent will be taken prior to any video recording and uploading of 
images. Video clips will be retained for the lifetime of the study to enable Liopa to 
improve the system over time and to run all data through at the conclusion of the 
study to provide updated accuracy results.  
 
5.1 
Data Variables 
All data will be collected by the research team and recorded in the study case report 
form (CRF).  
 
5.1.1 Baseline data  
           The following baseline data for all participants will be collected 24 hours  
           preceding recruitment into study: 
• 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 
These details will be collected from patients’ medical notes and relevant bedside 
documentation (i.e., observation and medication charts). 

 
 
23 
 
 
5.1.2 Daily data collected  
• CAM-ICU score (critical care patients only)   
• Frequency of SRAVI delivery 
• Compliance with SRAVI use  
• Adverse events 
 
5.1.3 Feasibility and clinical outcome data collected in acute/critical care  
• Screening 
• Recruitment rates 
• Adverse events 
• Delirium (critical care patients only) 
 
5.1.4 Data collected after critical care discharge 
• Duration of critical care stay 
 
Data collected during virtual/telephone/face to face follow-up 3 months following 
acute or critical care  discharge 
• Health related quality of life (HRQoL) 
• Post-Traumatic Stress Disorder (PTSD) 
• Anxiety and depression 
• Cognitive status 
    
5.2 
Quantitative Study Instruments 
Delirium screening is part of standard care across the three critical care study sites.  
It is determined using the CAM-ICU, a highly sensitive evaluation of delirium in 
critical care patients (57-59).  A healthcare professional completes a series of 
assessment variables and tests the patient for attention and cognition with a positive 
result (delirium present) or negative result (no delirium present).  
 
The EQ-5D is a generic health-related quality of life instrument which has been 
extensively validated and been shown to be reliable across many patient groups 
including critical care (60-61). It is a brief, simple questionnaire in which respondents 

 
 
24 
 
describe their current health state in five dimensions: mobility, ability to self-care, 
ability to undertake usual activities, pain and discomfort, and anxiety and depression. 
 
Anxiety and depressions will be measured using Hospital Anxiety and Depression 
Scale (HADS) (62).  A 14-item self-administered instrument it has been extensively 
validated with a review of 747 identified studies (63) concluding that HADS performs 
well in assessing symptom severity and case level of anxiety disorders and depression 
in somatic patients and gives clinically meaningful results as a psychological screening 
tool. The good reliability and stability of HADS have also been successfully 
demonstrated in in the aftermath of critical illness (64-65). 
 
PTSD will be measured using the Impact of Events Scale (Revised) (IES-R).  This is 
a 22-item self-report measure that assesses subjective distress caused by traumatic 
events.   It is a revised version of the 15-item IES (66) and contains seven additional 
items related to the hyperarousal symptoms of PTSD. Experts in long-term outcome 
by consensus have recommended the IES-R as one core outcome measure for mental 
health following critical illness (67). 
 
Cognitive status will be measured using the Montreal Cognitive Assessment (MoCA)-
BLIND screening instrument.  This 13-item instrument is a widely used measure in 
research to evaluate for cognitive impairment.  It assesses memory, attention, 
language, recall, orientation, and abstraction.  MoCA is the clinical instrument most 
applicable to use in the ICU population (68). 
 
5.3 
Data Analysis 
Descriptive analysis will be used to analyse data from the prospective 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).   
Twenty five percent of all data variables collected by the research fellow during 
baseline, intervention and follow-up phases of this study will be independently 

 
 
25 
 
reviewed by another clinician using the baseline, intervention, follow up and quality 
of life proformas devised for this study.   
 
6 
WITHDRAWAL FROM STUDY  
Participants may withdraw or be withdrawn (by patient or their Consultee or 
acute/critical care consultant responsible for their care) from the study at any time 
without prejudice. If the participant is withdrawn, the treating clinician responsible for 
their care will determine the safest and most appropriate way to continue the care 
outside of the study protocol.  Only anonymised data recorded up to the point of 
withdrawal will be included in the study analysis.  A log will be maintained that details 
number of participants withdrawn and the reasons for withdrawal.  
 
7. QUALITATIVE INTERVIEWS AND FOCUS GROUPS  
Interviews and focus groups will complement data from the prospective 
observational cohort study, providing a depth and breadth of understanding 
regarding the barriers and facilitators to the study design and intervention. Interviews 
and focus groups will be conducted by the research fellow with skills in interviewing 
vulnerable populations. Interview schedules and 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/guides will include a 
pre-defined list of questions that will be informed by the objectives of the study.  The 
schedule/guides will enable all participants to be asked similar questions and thus 
permit comparison of themes across each subject during data analysis (69).  
However, it will be flexible enough to allow the interviewer or interviewee to diverge 
to pursue an idea or response in greater detail. 
 
7.1        Process 
7.1.1 Patients and their significant others 
Individual, semi-structured, recorded interviews will be conducted with patients 
and/or their significant others to gain insight into their experience of communication 
whilst tracheostomised in acute or critical care.  Patients/significant others will be 
approached by a member of the direct care team in the period after critical care 
discharge and prior to imminent hospital discharge to ascertain if the research team 
can discuss the study interview with them.  If in agreement, a member of the 

 
 
26 
 
research team will undertake an assessment of suitability to participate in interviews. 
If this is not possible, interviews will be carried out at a location and time convenient 
to participants up to three months following acute/critical care discharge, either in 
hospital, in participants own homes, by telephone or by virtual online meeting as 
preferred.  Interviews will last between 30-60 minutes. 
 
7.1.2 Acute/Critical care MDT members  
Audio-recorded focus groups will be conducted with members of the MDT. 
Experiences, beliefs, and perceptions in using communication aids, including SRAVI, 
will be explored in addition to barriers and facilitators about recruitment, retention, 
and ease of collecting outcomes in the acute/critical care unit. Focus groups will take 
place either face-to-face, in a suitable location within the workplace, or virtually if 
necessary.  Staff will be invited to take part in the study during working hours with 
the permission of their line manager. Each focus group will last between 30-60 
minutes.   
 
If due to availability of clinical staff and if for participant convenience an individual 
interview is preferred, then an interview will take place.  Interviews will take place 
either face-to-face, in a suitable location within the workplace, or virtually if 
necessary.  Staff will be invited to take part in the study during working hours with 
the permission of their line manager. Each interview will last between 20-45 minutes. 
 
7.2 
Consent 
7.2.1 Patients and/or significant others 
Patients and relatives will be approached by a member of the direct care team to 
ascertain if they are willing to be contacted by the research team about participation 
in the study. Consent-to-be-contacted forms will also be available for interested 
relatives to complete. Consent will then be taken at the point of invitation by a 
member of the research team. A participant information sheet will be provided to 
patients and/or significant others who express an interest in joining the study. The 
participant information sheet will inform potential participants about the purpose of 
the qualitative interviews and what their role will be as well as their rights. 
7.2.2 Acute/Critical care MDT members 

 
 
27 
 
Acute and critical care staff will be informed about the study aims and methods at 
team meetings and daily briefs. A participant information sheet will be provided to staff 
who express an interest in joining the study.  Posters outlining details of the study  will 
be displayed at appropriate locations in each participating facility.  Posters will include 
contact details that interested staff can email should they wish to participate. 
    
Consent-to-be-contacted forms will also be available in each unit and interested staff 
can complete this form and leave it in a ‘voting box’ in a specified location on the ward 
for retrieval by study personnel.  Acute and critical care MDT members’ participation 
will start at the point of consent and finish at the end of the focus group or interview.  
At the time of focus groups or interviews, participants will be asked to review the study 
information sheet and sign a consent form, or verbally agree if the meeting is virtual. 
  
7.3 
Qualitative Data Collection 
With the permission of participants, all interviews and 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. Following transcription, audio-
recordings will be deleted. 
 
Subject to legislative requirements, including the UK General Data Protection 
Regulation (UKGDPR) (70), all transcripts and consent forms will be securely stored 
either electronically on a password-protected computer or in a locked cabinet in QUB 
to which only the research team will have access.  Consent forms will be locked 
separately from transcripts. 
 
7.4 
Qualitative Data Analysis 
Analysis will be carried out concurrent with data collection so that new information 
can be incorporated into subsequent interviews. Qualitative data will be subjected to 
a thematic analysis, using Newell and Burnard’s (71) 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-

 
 
28 
 
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.  
  
To reduce the element of lone researcher bias and to make analysis more rigorous, 
codes will be verified by a second party, the research fellow’s supervisor.  This has 
been chosen in favour of participant validation which may be hindered by 
participants changing their perceptions because of temporal effects post critical 
illness or potential changes in their situations.  To further promote integrity and 
reliability during the data analysis process, other strategies will be introduced. Field 
notes will be written immediately after each interview and a reflective diary 
maintained, aiming to reduce the potential for the researcher’s values, beliefs, and 
preconceptions to influence subsequent findings.  
 
8. SAFETY REPORTING  
This study is considered to be low risk as the intervention is a communication aid, 
carrying minimal health risks.  SRAVI has been registered with the MHRA, and CE 
marked for intended use.  In line with MHRA guidance, the device will fully comply 
with the requirements of The Medical Device Regulations (2017/745). 
 
8.1 
Definitions  
All adverse events (AEs) which occur during the course of participants’ involvement 
in this study will be appropriately recorded and reported in order to ensure their 
continuing safety. AEs will be classified according to the following categories: 
• Adverse Event  
• Adverse Device Effect (ADE)  
• Serious Adverse Event  
• Serious Adverse Device Effect (SADE)  
• Unanticipated Serious Adverse Device Effect (USADE) 
 
8.1.1 Adverse Event 

 
 
29 
 
An AE is defined as any untoward medical occurrence in a study participant.  Events 
and complications associated with the patient’s underlying medical condition will not 
be considered adverse events (AE).   
 
8.1.2 Adverse Device Effect (ADE)  
An Adverse Event (AE) related to the use of an investigational medical device. This 
includes any AE resulting from insufficiencies or inadequacies in the instructions for 
use, the deployment, implantation or operation of the medical device or any 
malfunction. This also includes any AE that is a result of an error in use or intentional 
misuse of the medical device. 
 
8.1.3 Serious Adverse Event 
A serious adverse event (SAE) is defined as an untoward occurrence that: 
• Results in death 
• Is life-threatening  
• Requires hospitalisation or prolongation of existing hospitalisation  
• Results in persistent or significant disability or incapacity 
• Is any other important medical event(s) that carries a real, not hypothetical, risk 
of one of the outcomes above 
 
8.1.4 Serious Device Effect (SADE)  
An Adverse Device Effect (ADE) that results in:  
• Death 
• Life threatening illness or injury  
• Hospitalisation, or prolongation of existing hospitalisation 
• Persistent or significant disability or incapacity 
• Is otherwise considered medically significant by the Investigator  

 
 
30 
 
8.1.5 Unanticipated Serious Adverse Device Effect (USADE)  
Serious adverse device effect which by its nature, incidence, severity, or outcome has 
not been identified in the current version of the risk analysis report. 
 
8.2 
Assessment of Causality 
AEs will be clinically assessed by the PI or medically qualified designee at each study 
site for causality based on the available information, i.e., the relationship of the AE to 
the intervention. Causality assessment decisions must be made by a medically 
qualified doctor.   For the purposes of this study the causality should be assessed 
using the categories below.  
 
Unrelated: There is no evidence of any causal relationship to the medical device  
Unlikely: The relationship with the use of the investigational medical device seems 
not relevant and/or the event can be reasonably explained by another cause.  
Possible: The relationship with the use of the device is weak but cannot be ruled out 
completely  
Probable: The relationship with the investigational medical device seems relevant 
and/or the event cannot be reasonably be explained by another cause.  
Causal Relationship: The serious event is associated with the investigational medical 
device beyond reasonable doubt. 
 
8.3 
Reporting and Recording 
AEs and SAEs will be recorded and reported for each patient until acute/critical care 
discharge.  All reported AEs and SAEs will be recorded in the medical notes of the 
patients. 
 
Risks within this study are considered to be minimal. It is considered highly unlikely 
that participants will suffer any adverse consequences as a result of receiving SRAVI 
plus usual care. If in the opinion of a registered medical practitioner in acute/critical 
care, an SAE that occurs to a research participant is classified as: 
• Related: that is, it resulted from delivery of the intervention, and 

 
 
31 
 
• Unexpected: that is, the type of event or complication not expected or 
associated with the patient’s underlying medical condition and recovery period 
in acute/critical care  
then the CI will be responsible for expedited reporting of the SAE to the sponsor and 
the REC which issued the favourable ethical opinion.  This will be done within 24 
hours of the event occurring.  If it is determined that the serious adverse event is 
related, then the intervention will be promptly discontinued and recorded in case 
report form. 
 
Low risk to participants will be further ensured through confidential and anonymous 
storing of their data and giving participants the opportunity to express their thoughts 
and opinions about the intervention they received without judgement or influence. 
The research team will ensure that the needs of the study are not placed above the 
wellbeing of participants.  Although physical harm is unlikely in this study, risks can 
also include psychosocial harm.  Traumatic memories may be triggered, and questions 
asked during interviews might bring to the surface distress which participants might 
wish to discuss.  As an experienced critical care nurse, the research fellow will 
undertake interviews.  Should any participant become distressed the interview will be 
stopped.  Additionally, the research fellow will plan for provision of information about 
services which participants might solicit to discuss their needs. 
 
The research team will also be sensitive to the expectations and opinion of participants 
regarding potential benefits of the research.  Prior to the commencement of the study, 
the research fellow will formally discuss these expectations with individuals.  
Participants will also be debriefed at the study conclusion to provide information, clarify 
any issues or misconceptions and to monitor any negative effects which were 
unforeseen and require intervention. 
 
9. 
End of study  
The study will be stopped prematurely if: 
• Mandated by REC 
• Mandated by the Sponsor  
• Funding for the study ceases 

 
 
32 
 
The REC that originally gave a favourable opinion of the study will be notified in 
writing once the study has been concluded or if it is terminated early. 
 
10. 
ETHICAL & REGULATORY CONSIDERATIONS 
Ethical Approval: The study will be conducted in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki.  To protect the rights, 
safety wellbeing and dignity of the participants who may potentially be involved in 
this study, the study protocol will be approved by the Office for Research Ethics 
Committees Northern Ireland.   
Good Clinical Practice: The study will comply with the principles of GCP, the 
requirements and standards set out by the EU directive 2001/20/EC and the 
applicable regulatory requirements in the UK and the Research Governance 
Framework. 
 
10.1 Access to Study Data 
In agreement with the CI, the study team will provide direct access to source data 
and study related documentation for all study related monitoring, audits, ethics 
committee review and regulatory inspections.  Consent from patients and/or family 
members for direct access to data will also be obtained.  The patients’ confidentiality 
will be maintained and will not be made publicly available to the extent permitted by 
the applicable laws and regulations.  
  
10.2 Study Committees 
Data integrity and study credibility depends on factors such as ensuring adherence 
to study protocols and using quality control measures to establish high standards for 
data quality.   
 
10.2.1 Study Management Group 
The Study Management Group (SMG) will be established and chaired by the CI.  This 
group will have responsibility for the day-to-day operational management of the study 
and regular meetings of the SMG will be held to discuss and monitor progress.  The 
discussions of the SMG will be formally minuted and a record kept in the Main Study 

 
 
33 
 
File. A SMG consisting of the CI, research fellow and nominated co-investigators will 
meet bi-monthly, and the CI will chair meetings. 
 
10.2.2 Patient advisory group 
The patient advisory group has been convened and will be involved for the duration 
of the study until summary findings have been disseminated to the general public 
and relevant acute/critical care patient groups.  This group involves six adults who 
previously experienced a tracheostomy whilst in acute/critical care.  They have been 
involved and formed part of a larger focus group (including general members of the 
public) who were consulted when the research fellow was developing the proposed 
intervention for this study.  They have provided valuable feedback on the proposed 
intervention and patient-related materials for this study (i.e., consent forms, patient 
information leaflets).  They have also provided novel insights for the study team on 
the outcomes that were important to them while tracheostomised in acute/critical 
care.  All past-patient members of the focus group reported that their main outcome 
from a communication intervention would be for it to be easy to use and enable 
better understanding between healthcare professionals, relatives, and patients. 
The research fellow will agree to keep the patient advisory group updated on study 
developments as the study progresses.  At the end of the study, the research fellow 
and the patient advisory group will co-design and co-write the lay summary of 
findings from this study, which will be disseminated to members of the general public 
and laryngectomy and intensive care-related patient and family support groups.  
 
10.3 Sponsorship 
QUB will act as Sponsor for the study and the CI will take overall responsibility for 
the conduct of the study.   
 
10.4 Funding  
This study is funded by the Research and Development Division of the Public Health 
Agency (PHA), NI as part of a Doctoral Fellowship. 
 
10.5 Contributorship  

 
 
34 
 
The CI and all co-investigators contributed to the study design and along with the 
SMG were involved in the development and finalisation of the protocol.   
 
10.6 Patient and Public Involvement 
This study has a patient advisory group.  Details outlined in section 10.2.2 of this 
protocol. 
 
10.7 Competing interests 
There are no conflicts of interest in this study and no commercial funding provided 
for this project.  The project has been funded by the Research and Development 
division of the PHA, NI. 
 
10.8 Indemnity 
QUB will provide indemnity for the negligent and non-negligent harms caused to 
patients by the design of the research protocol.  
 
10.9 Study protocol compliance  
A protocol deviation is defined as an incident which deviates from the normal 
expectation of a particular part of the study process.  Any deviations from the 
protocol will be fully documented.   
 
A serious breach is defined as a deviation from the study protocol or GCP which is 
likely to effect to a significant degree: 
• The safety or physical or mental integrity of the subjects of the study 
• The scientific value of the study 
The site principal investigator will be responsible for ensuring that serious breaches 
are reported directly to the CI and Sponsor within one working day of becoming 
aware of the breach.  
 
10.9.1 Protocol amendments 
The CI will conduct the study in compliance with the protocol given approval/ 
favourable opinion by the Ethics Committee and the appropriate regulatory authority.  
Changes to the protocol may require competent authority/ethics committee 

 
 
35 
 
approval/favourable opinion prior to implementation, except when modification is 
needed to eliminate an immediate hazard to patients.  The CI in collaboration with 
the sponsor will submit all protocol modifications to the competent authority/research 
ethics committees for review in accordance with the governing regulations.  Any 
deviations from the protocol will be fully documented on the protocol deviation form 
in the case report form. 
 
10.9.2 Patient confidentiality 
The participant’s study identifier, name, address, and other contact details of all 
patients will be kept separate.  The CI or co-investigator will keep these details in a 
locked filing cabinet.  All documentation regarding the study will identify the patients 
by the assigned unique study identifier.  Computers where information will be stored 
will be password protected.  Patient confidentiality will be maintained at every stage 
and will not be made publicly available to the extent permitted by the applicable laws 
and regulations.  Due care will be taken to ensure data safety, integrity, and 
compliance with the Data Protection Act.   
 
11. 
DISSEMINATION POLICY 
11.1 Study results 
The prospective observational cohort study will be reported in accordance with the 
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) 
guidelines (71). To ensure adequate reporting of qualitative data, the Consolidated 
Criteria for Reporting Qualitative Research (COREQ-32) item checklist (72), a 
consolidated reporting framework for qualitative designs will be followed.  
Dissemination will be achieved in several ways.  We will present findings at national 
and international meetings with open access abstracts online.  We will also aim to 
publish the findings in high quality peer-reviewed open access journals.  This will 
ensure that results are readily accessible to the public, healthcare professionals and 
scientists.  We will also share a summary of the main study findings with ICU Steps 
(a patient support group for members of the public who have experienced a critical 
care stay in the past) and relevant laryngectomy support groups.  We will also 
disseminate results to the British Association of Critical Care Nurses (BACCN), the 
Global Tracheostomy Collaborative and Intensive Care Society. 
 

 
 
36 
 
11.2 Authors 
The CI, co-investigators and members of the study team who contributed to the 
design, conduct, interpretation, and reporting of this study will be recognised by 
granting them authorship on the final study report.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
37 
 
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