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Trial registered on ANZCTR


Registration number
ACTRN12613000577718
Ethics application status
Approved
Date submitted
21/05/2013
Date registered
22/05/2013
Date last updated
22/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of nasogastric tubes on swallowing physiology in older healthy volunteers: A randomised controlled trial
Scientific title
Older healthy volunteers and the impact of nasogastric tube presence or absence on swallowing physiology
Secondary ID [1] 282504 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia (disorder of swallowing)
 289158 0
Condition category
Condition code
Oral and Gastrointestinal 289484 289484 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers are required to undergo three modified barium swallow (MBS) studies in one day of testing. During each MBS volunteers will swallow:
- 3 sips of liquid & barium sulphate (ratio 2:1)
- 100ml serial swallows of liquid & barium (ratio 2:1)
- 3x15ml puree fruit & barium (ratio 3:1)
- 3x15ml diced fruit & barium (ratio 3:1)

Each MBS will be assigned a different study condition:
- control (no nasogastric tube)
- experimental (fine bore nasogastric tube insitu)
- experimental (wide bore nasogastric tube insitu)

Radiological screening time for each MBS will be 2-3 mins. Skin fluoro time and skin effective dose data will be collected and monitored to ensure total effective dose does not exceed 2 milliseverts as per ethics protocol.

There will be a minimum 30 minute break between the control and first experimental condition, and minimum 60 minutes between the first and second experimental conditions.
Intervention code [1] 287177 0
Treatment: Devices
Comparator / control treatment
The control is to undergo a modified barium swallow (MBS) without a nasogastric tube insitu (ie. a normal baseline swallow)
Control group
Active

Outcomes
Primary outcome [1] 289606 0
A change in the 8 point penetration-aspiration scale (PAS)
Timepoint [1] 289606 0
Every swallow recorded for each volunteer will be rated following the uploading of MBS images to IMPAX (hospital integrated review and reporting system).
Secondary outcome [1] 302837 0
A change in a 4 point pharyngeal residue severity scale.
Timepoint [1] 302837 0
Every swallow recorded for each volunteer will be rated following the uploading of MBS images to IMPAX (hospital integrated review and reporting system).
Secondary outcome [2] 302838 0
A change in the duration of pharyngeal transit (temporal measures of swallowing). Images are recorded in 300 frame loops of 15 per second - one frame equals 0.067 seconds. Duration of pharyngeal transit is calculated by counting the number of frames for this swallowing stage, and multiplying by 0.067 seconds.
Timepoint [2] 302838 0
Every swallow recorded for each volunteer will be rated following the uploading of MBS images to IMPAX (hospital integrated review and reporting system).

Eligibility
Key inclusion criteria
Healthy volunteers aged 60 years and over
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous medical history associated with swallowing dysfunction: including disease, illness or injury affecting the central nervous system; surgery or treatment to structures of the head, neck and digestive tract; any medications known to interfere with swallowing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment if volunteer meets inclusion criteria and provides signed consent for participation. Allocation to intervention order presented in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There was insufficient data to perform a pre-study power calculation. A similar crossover study used 10 participants.

Analysis using Stata/SE 12.1 (StataCorp LP).
Analysis of continuous data using ANOVA and post-hoc paired t-tests. Analysis of categorical data using the Friedman test with post-hoc Wilcoxon signed rank test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2012
Actual
25/02/2012
Date of last participant enrolment
Anticipated
5/05/2012
Actual
5/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1037 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6899 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287312 0
Charities/Societies/Foundations
Name [1] 287312 0
Allied Health Grant
Royal Adelaide Hospital Research Foundation
Country [1] 287312 0
Australia
Primary sponsor type
Individual
Name
Lee Pryor
Address
Speech Pathology Department
Royal Adelaide Hospital
North Terrace, Adelaide
South Australia, 5000
Country
Australia
Secondary sponsor category [1] 286061 0
Individual
Name [1] 286061 0
Professor Elizabeth Ward
Address [1] 286061 0
School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane
QLD 4072
Country [1] 286061 0
Australia
Other collaborator category [1] 277413 0
Individual
Name [1] 277413 0
Associate Professor Marianne Chapman
Address [1] 277413 0
Director of Research
Intensive Care Unit
Royal Adelaide Hospital
North Terrace, Adelaide
SA 5000
Country [1] 277413 0
Australia
Other collaborator category [2] 277414 0
Individual
Name [2] 277414 0
Stephanie O'Connor
Address [2] 277414 0
Research Coordinator
Intensive Care Unit
Royal Adelaide Hospital
North Terrace, Adelaide
SA 5000
Country [2] 277414 0
Australia
Other collaborator category [3] 277415 0
Individual
Name [3] 277415 0
Dr Petrea Cornwell
Address [3] 277415 0
Principal Research Fellow
Metro North Hospital & Health Service
15 Butterfield St, Herston
QLD 4029
Country [3] 277415 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289285 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 289285 0
Ethics committee country [1] 289285 0
Australia
Date submitted for ethics approval [1] 289285 0
30/11/2011
Approval date [1] 289285 0
14/12/2011
Ethics approval number [1] 289285 0
111211

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

Contacts
Principal investigator
Name 40046 0
Ms Lee Pryor
Address 40046 0
Speech Pathology Department,
Royal Adelaide Hospital,
North Terrace, Adelaide,
SA 5000
Country 40046 0
Australia
Phone 40046 0
+61 08 8222 5524
Fax 40046 0
Email 40046 0
lee.pryor@health.sa.gov.au
Contact person for public queries
Name 40047 0
Lee Pryor
Address 40047 0
Speech Pathology Department,
Royal Adelaide Hospital,
North Terrace, Adelaide,
SA 5000
Country 40047 0
Australia
Phone 40047 0
+61 08 8222 5524
Fax 40047 0
Email 40047 0
lee.pryor@health.sa.gov.au
Contact person for scientific queries
Name 40048 0
Lee Pryor
Address 40048 0
Speech Pathology Department,
Royal Adelaide Hospital,
North Terrace, Adelaide,
SA 5000
Country 40048 0
Australia
Phone 40048 0
+61 08 8222 5524
Fax 40048 0
Email 40048 0
lee.pryor@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.