Fibreoptic endoscopic evaluation of swallowing (FEES): Therapy or Assessment

ISRCTN	ISRCTN48558760
DOI	https://doi.org/10.1186/ISRCTN48558760
Secondary identifying numbers	N0515163804

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 20/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Trudi Minns
Scientific

Regional Rehabilitation Unit
North West London Hospitals NHS Trust
Northwick Park Hospital
Watford Road
Harrow
HA1 3UJ
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Scientific title	Fibreoptic endoscopic evaluation of swallowing (FEES): Therapy or Assessment
Study objectives	The hypothesis is that visual & verbal feedback improves the ability of participants to correctly perform specific movements within the pharynx to command. In addition to this I am hypothesising that FEES is a valuable therapeutic tool with regards to comfort, acceptability, time and resources. To date there is no documented evidence supporting the use of Nasendoscopy as a therapeutic tool, despite the obvious clinical benefits.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Deglutition disorders
Intervention	Group 1 Participants of the study will be assigned to one of two groups. All participants will be given information about the anatomy of the pharynx and larynx. This will be done using diagrams. With the aid of the diagram, the participant will then be given information about the precise target movements expected of them. These include: Nasopharyngeal closure, tongue base reaction, vocal fold adduction and the posterior pharyngeal wall. The scope will then be passes transnasally to enable three views the nasopharyngeal port, the pharynx and the larynx. Participants randomised to group 2 will be positioned to allow viewing of their anatomy. The whole assessment process will be videotaped to allow for inter-rate reliability to be established. The participant will be instructed to attempt to each movement in turn and they will be given 3 minutes to perfect this movement. The participant will then be instructed to attempt to perform the movement 5 times consecutively. The movement will be scored as present or absent and a score out of 5 will be given. Group 2 participants will be scoped as before to allow the therapist full view of the movements achieved in the pharynx and this that are not. The participant will not however be able to view the monitor. The participants in this group will receive the same amount of feedback that would normally be available for patients receiving therapy with out the help of nasendoscopy. The investigator will provide them with information about the target movements. Group 2 participants will be given a practice period of 3 minutes per movement. The participant will then be asked to perform the target movements 5 times and the researcher will record the consistency with which they are achieved. As with group 1, all the assessment results will be recorded on to videotape. The assessment time in total should not exceed 20 minutes. Analysis of the results will be achieved using a chi squared statistical test.
Intervention type	Other
Primary outcome measure	Measurement of the target movement. Assessment as to whether or not these movements have been achieved will be rate by the principal investigator and the data will be re-rated by a further therapist skilled in this area
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/2002
Completion date	31/03/2006

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Participants will be selected and randomly assigned into two groups. Each group will consist of 10 healthy volunteers with no history of swallowing difficulties. Participants will be recruited predominantly from staff working at Northwick Park Hospital.
Key exclusion criteria	1. Patients under 18 2. Patients with swallowing difficulties
Date of first enrolment	01/07/2002
Date of final enrolment	31/03/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Northwick Park Hospital

Harrow
HA1 3UJ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

North West London Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan