Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001369718
Ethics application status
Approved
Date submitted
17/10/2022
Date registered
25/10/2022
Date last updated
25/10/2022
Date data sharing statement initially provided
25/10/2022
Date results provided
25/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mobile Flexible Endoscopic Evaluation of Swallowing (mFEES) in Adults in Residential Aged Care Homes (RACHs): a feasibility study
Scientific title
Mobile Flexible Endoscopic Evaluation of Swallowing in Adults in Residential Aged Care Homes: a feasibility study
Secondary ID [1] 306166 0
None
Universal Trial Number (UTN)
U1111-1273-1559
Trial acronym
mFEES in RACHs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 324876 0
Condition category
Condition code
Diet and Nutrition 322312 322312 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 325053 325053 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: A single session of flexible endoscopic evaluation of swallowing (FEES) was provided to residents who were referred by their treating speech pathologists for assessment if (i) they consent to the procedure, (ii) met safety criteria, and (iii) a treating medical practitioner (e.g., GP, geriatrician) supported the assessment.

The duration of assessment (between 15m-35m), the textures of food and fluids presented, the number of oral trials and strategies to optimise swallowing safety, efficiency and comfort were tailored to the individual needs of each resident based on the speech pathologist's clinical findings and the resident's choices.

The FEES involved passing a thin flexible endoscope connected to a light source, camera, and video-recording equipment transnasally to the level of the nasopharynx, oropharynx, and hypopharynx. During the FEES the resident was required to: (i) perform a series of behavioural tasks (e.g., puffing out of cheeks, poking out the toungue, phonation tasks, coughing, swallowing saliva, and breath holding); (ii) swallow oral intake; and (iii) watch the video screen for biofeedback (if appropriate). This enabled the endoscopist to assess the resident's pharyngeal and laryngeal structures and function related to swallowing. When clinically indicated, the endoscopist directed the resident to implement specific behavioural strategies to assess their impact on swallowing safety, efficiency, and comfort (e.g., taking small mouthfuls, flexing the neck during the swallow, concentrating before swallowing, breath holding during the swallow)

The minimum number of oral trials that participants were instructed to complete were 3 x trials of fluids and 3 x trials of food. Fluid consistencies ranged from thin (IDDSI L0) to mildly thick (IIDSI L2) to moderately thick (IDDSI L3). Food consistencies ranged from pureed (IDDSI L4), to minced and moist (IDDSI L5), to soft (IDDSI L6), to regular food (IDDSI L7).

Within 7 days from the FEES procedure, the endoscopist (research speech pathologist) and a consulting otolaryngologist/ speech pathologist analysed the FEES recording to produce a report describing: (i) airway protection mechanisms; (ii) pharyngeal/ laryngeal sensation; (iii) pharyngeal swallow function; (iv) morphological observations; and (v) secretion management. This report contained written information and photo images that could be used by the facility (treating speech pathologist) to: (i) formulate a tailored swallowing management plan (e.g., prescribe specific food/ fluid consistencies, prescribe exercises to strengthen muscles for swallowing, prescribe the manner of oral intake such as small mouthfuls and rest between swallows) ; (ii) educate the resident and their healthcare team about the resident's swallowing function; (iii) formulate a more specific dysphagia prognosis. It was not the role of the endoscopist to provide swallowing management recommendations because the treating speech pathologist was in a better position to facilitate a multidisciplinary management plan due to their ongoing, wholistic knowledge of the resident and the ability to incorporate resident choice into care options.

Where: FEES was provided onsite in the resident's bedroom in the residential aged care home

Who: A speech pathologist conducted the endoscopy and guided oral feeding during the FEES. The RACH division one nursing staff member, who was familiar with the resident, administered the food/ fluids during the assessment as per the speech pathologist's directions. An on-call otolaryngologist was available via telephone and online media, if assistance was sought by the speech pathologist, to offer advice about anatomical concerns. Recordings of the FEES were analysed by two experienced speech pathologists, with optional input from the otolaryngologist on a needs basis. The report was prepared within one week of assessment by the speech pathologist who conducted the FEES. This report was provided to the referring speech pathologist and the RACH where the resident lived.

Fidelity: Data were collected on the number and nature of adverse events occurring during the FEES and the number of adults who tolerated the procedure.
Intervention code [1] 324643 0
Diagnosis / Prognosis
Intervention code [2] 324644 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332817 0
Area of consideration: feasibility

Level of analysis: Resident

Outcome measure: referral response rate (in days)- calculated from the day of mFEES referral to the day of the mFEES

Data source: Recorded by the research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on her records of referral receipt and the FEES procedure.
Timepoint [1] 332817 0
Calculated for each resident on the day of the mFEES
Primary outcome [2] 332822 0
Area of consideration: feasibility

Level of analysis: implementation

Outcome measure: percentage of successful mFEES completed (successful = nasendoscope successfully inserted and the procedure is terminated based on the clinical needs of the resident)

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on clinical observations by the endoscopist
Timepoint [2] 332822 0
Calculated at the end of the study
Primary outcome [3] 332825 0
Area of consideration: acceptability

Level of analysis: resident

Outcome measure: number and nature of procedural (FEES-related) adverse events

Examples of adverse events include: epistaxis, laryngospasm, vasovagal episode (fainting)

Data source: Recorded by the research speech pathologist based on clinical examination by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne
Timepoint [3] 332825 0
Calculated at the conclusion of each FEES procedure
Secondary outcome [1] 414787 0
Area of consideration: feasibility

Level of analysis: Implementation

Outcome measure: considerations in the physical set-up of the procedural space for the mFEES

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on clinical observations by the endoscopist
Timepoint [1] 414787 0
On the day of the mFEES
Secondary outcome [2] 414795 0
Area of consideration: feasibility

Level of analysis: resident

Measures used: referral rate- number of referrals obtained during the study period (measured in months)

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [2] 414795 0
Calculated at the end of the study period
Secondary outcome [3] 414796 0
Area of consideration: feasibility

Level of analysis: implementation

Measures used: percentage of appropriate referrals

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [3] 414796 0
Calculated at the conclusion of the study period
Secondary outcome [4] 414797 0
Area of consideration: feasibility

Level of analysis: implementation

Measures used: percentage of eligible residents referred by their treating speech pathologists who agreed to the FEES

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [4] 414797 0
Calculated at the conclusion of the study
Secondary outcome [5] 414798 0
Area of consideration: feasibility

Level of analysis: RACH

Outcome measure: cost of personal protective equipment supplied by the RACH per mFEES

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [5] 414798 0
Cost calculated at the conclusion of the study
Secondary outcome [6] 414799 0
Area of consideration: feasibility

Level of analysis: RACH

Outcome measure: RACH division 1 nursing staff time per mobile FEES

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [6] 414799 0
Recorded on the day of the mobile FEES
Secondary outcome [7] 414800 0
Area of consideration: feasibility

Level of analysis: implementation

Outcome measure: SLP (speech-language-pathologist) time in minutes per FEES (measure includes travel time to provide FEES, time onsite the RACH, and FEES report preparation time)

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records
Timepoint [7] 414800 0
Calculated at the end of each FEES episode of care related to one resident
Secondary outcome [8] 414801 0
Area of consideration: feasibility

Level of analysis: implementation

Outcome measure: cost of individual FEES assessment (includes: mFEES equipment/perishables, personal protective equipment)

Data source: Calculated based on equipment used as documented by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on research study records AND liaison with residential care facilities about equipment costs
Timepoint [8] 414801 0
Calculated at the conclusion of the each FEES related episode of care
Secondary outcome [9] 414802 0
Area of consideration: acceptability

Level of analysis: resident

Outcome measure: Duration of the FEES procedure in minutes

Data source: Recorded by the endoscopist/research speech pathologist into a study specific database (REDCap) housed at the University of Melbourne based on duration of the FEES video recordings
Timepoint [9] 414802 0
Calculated at the conclusion of each FEES episode
Secondary outcome [10] 414803 0
Area of consideration: acceptability

Level of analysis: resident

Outcome measure: resident rated pre-procedural anxiety level (measured using the Visual Anxiety Scale for Assessing pre-operative anxiety)
Timepoint [10] 414803 0
Rated by residents on the day of the FEES
Secondary outcome [11] 414804 0
Area of consideration: acceptability

Level of analysis: resident

Outcome measure: procedural discomfort self-rated by residents using the Faces Pain Scale -Revised
Timepoint [11] 414804 0
Rated by residents on the day of the FEES

Eligibility
Key inclusion criteria
Inclusion criteria for residents:
- 18 years or older
- Resident identified with potential to benefit from FEES by their treating speech pathologist
- Approved for FEES by their treating general practitioner or geriatrician

Inclusion criteria for participating RACHs:
- the speech pathology service servicing the RACH expresses verbal agreement to support the FEES study
- the RACHs is able to give the research speech pathologist access to medical records of consenting participants to collect basic demographic information about the participants, information about their swallow and any factors that may influence the adult’s capacity to provide informed consent
- the RACH can provide a quite, clean, private area greater than 2 by 2 meters in size, with a sink and an emergency call button, where the mobile FEES procedure can be performed (including nasendoscope preparation, cleaning and participant assessment)
- the RACH is able to allow a division one (or above) nursing staff member (eg. clinical care manager) to:

a) inform the researcher if the participant has allergies, intolerances or medical conditions that could be compromised through the provision of inappropriate oral intake (e.g., adult requires a diabetic, gluten free or a low sodium diet, adult is on a strict fluid restriction)

b) be present throughout the mobile FEES procedure (approximately 15 minutes) and if necessary, provide the participant with food and drinks, as prepared and instructed by the research speech pathologist

-the RACH can provide some of the following items, if requested by the student researcher:
plastic examination gloves; 4 x teaspoons; 1 x tablespoon; 1 x fork; 4 x glasses of cordial (200m each); 1 x plate; 1 cup of tea/ coffee (on request); 1 dry cracker or biscuit; 1 slice of bread with butter; 1 banana; canned diced fruit (eg. peach or apricot); 1 tub of yogurt

- provide food/ fluids for assessment in addition to materials specified above in the following circumstances: it is medically indicated due to the participant’s intolerance(s)/ allergy(ies) or medical condition(s); the student researcher believes that it is appropriate to trial foods/fluids that are familiar and/or problematic for the participant; the participant expresses a preference for familiar food/ fluids

c) allow the student researcher timely and unobstructed access to the participant’s medical file so that she can screen the file for any contraindications to assessment on the day of the assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for residents:
- unstable cardiac condition
- unstable neurological condition e.g., in the
- process of a suspected stroke
- moderate-to-severe behavioural agitation,
- distress or aggression
- oxygen requirements exceed levels provided
- through nasal prongs ( > 5L/ min)
- severe movement disorder with hyperkinetic movements
- history or risk of severe epistaxis
- history of recurrent vasovagal episodes
- recent facial fractures or surgery
- known severe hypersensitivity of the nose and/ or nasopharynx and/ or oropharynx
- active infectious disease/ condition requiring - physical isolation from other residents
- bilateral nasal obstruction
- base of skull fracture
- identified by the treating speech pathologist as not having an adequate understanding of English, due to non-English speaking background, to consider the plain language statement and to make an informed decision about study participation
- medically ‘highly vulnerable’ as indicated by the treating GP/ Geriatrician in discussion with the research speech pathologist*

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The target was 20 participants to ensure that basic descriptive statistics could be used to capture the population of adults referred for the study, the incidence of adverse events, as well as subjective ratings of pre-procedural anxiety and procedural pain reported by the residents.

Descriptive narrative would be used to summarise the remaining outcomes of this feasibility study.

This feasibility study involved recruitment of residents from RACHs to participate in aerosol generating procedures during the peak of the 2020/21 global pandemic in Victoria. Due to practical difficulty in participant recruitment under these conditions, the researchers agreed to accept the maximum number of participants that could be recruited during the nominated data collection period (available under the terms of the student researcher's PhD scholarship program).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
25/10/2021
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
20
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 38761 0
3824 - Narracan
Recruitment postcode(s) [2] 38762 0
3450 - Castlemaine
Recruitment postcode(s) [3] 38763 0
3224 - Leopold
Recruitment postcode(s) [4] 38764 0
3363 - Creswick
Recruitment postcode(s) [5] 38765 0
3181 - Windsor
Recruitment postcode(s) [6] 38766 0
3450 - Moonlight Flat
Recruitment postcode(s) [7] 38767 0
3460 - Daylesford
Recruitment postcode(s) [8] 38768 0
3953 - Leongatha
Recruitment postcode(s) [9] 38770 0
3444 - Kyneton
Recruitment postcode(s) [10] 38771 0
3752 - Morang South
Recruitment postcode(s) [11] 38772 0
3953 - Leongatha North

Funding & Sponsors
Funding source category [1] 310511 0
Government body
Name [1] 310511 0
receiving Australian Government Research Training Scholarship funding
Country [1] 310511 0
Australia
Funding source category [2] 312454 0
Government body
Name [2] 312454 0
National Health and Medical Research Council
Country [2] 312454 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
550 Swanston Street Carlton, VIC, 3010
Country
Australia
Secondary sponsor category [1] 314032 0
None
Name [1] 314032 0
Address [1] 314032 0
Country [1] 314032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310136 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 2) - Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 310136 0
Ethics committee country [1] 310136 0
Australia
Date submitted for ethics approval [1] 310136 0
Approval date [1] 310136 0
08/02/2021
Ethics approval number [1] 310136 0
021-13387-13943-2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116602 0
Prof Adam Vogel
Address 116602 0
Audiology and Speech Pathology
Medicine, Dentistry and Health Sciences Division
The University of Melbourne
550 Swanston Street, Carlton, VIC, 3010,
Country 116602 0
Australia
Phone 116602 0
+61 390355334
Fax 116602 0
Email 116602 0
[email protected]
Contact person for public queries
Name 116603 0
Olga Birchall
Address 116603 0
Department of Audiology and Speech Pathology
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne, Victoria 3010 Australia
550 Swanston Street, Carlton
Country 116603 0
Australia
Phone 116603 0
+61401490428
Fax 116603 0
Email 116603 0
[email protected]
Contact person for scientific queries
Name 116604 0
Olga Birchall
Address 116604 0
Department of Audiology and Speech Pathology
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne, Victoria 3010 Australia
550 Swanston Street, Carlton
Country 116604 0
Australia
Phone 116604 0
+61401490428
Fax 116604 0
Email 116604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect participant confidentiality, given the small sample size and the highly specific nature of the intervention, data will be shared and published in aggregated form


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17377Informed consent form  [email protected] On request from the researcher
17378Ethical approval  [email protected] On request from the researcher
17380Clinical study report  [email protected] On request from the researcher



Results publications and other study-related documents

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