Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000752066
Ethics application status
Approved
Date submitted
9/08/2010
Date registered
10/09/2010
Date last updated
10/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing swallowing in stroke patients - free water versus thickened fluids
Scientific title
In stroke patients who aspirate thin liquids does a free water protocol increase fluid intake and improve hydration status without increasing the risk of pneumonia when compared to the provision of thickened fluids only ?
Secondary ID [1] 252405 0
Royal Adelaide Hospital Protocol 090430a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 257916 0
Stroke 258166 0
Condition category
Condition code
Stroke 258083 258083 0 0
Ischaemic
Stroke 258345 258345 0 0
Haemorrhagic
Oral and Gastrointestinal 258346 258346 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
Free Water Protocol.
Allowing aspirating patients access to water between meals but not with food or drink. They also have access to thickened fluids at their bedside and at mealtimes and can choose whether they drink thickened fluids or water. Patients will remain on this protocol until they are assessed as no longer aspirating. The protocol includes a strict oral hygiene regime of twice daily teeth brushing and rinsing mouth after all food..
Intervention code [1] 256971 0
Treatment: Other
Comparator / control treatment
Thickened fluids.
Providing fluids thickened to the consistency which prevents aspiration. Thickened fluids are provided at bedside and at all mealtimes. Patients will remain on thickened fluids until they are assessed as no longer aspirating. They will also undergo the same oral hygiene regime as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 258944 0
Average daily fluid intake measured in mls.
This will be recorded by nursing staff on a fluid balance chart which records fluid offered and fluid drunk.
Water and thickened fluids drunk will be totalled separately.
Timepoint [1] 258944 0
Measured daily until patient is assessed as no longer aspirating or is discharged from hospital, whichever comes first.
Primary outcome [2] 258945 0
Incidence of pneumonia as diagnosed by medical officer and confirmed by chest Xray
Timepoint [2] 258945 0
Chest monitored clinically on a daily basis until patient is assessed as longer aspirating and chest Xray ordered as required
Primary outcome [3] 258946 0
Hydration status measured by urea to creatinine ratio from biochemical analysis of a blood sample
Timepoint [3] 258946 0
Blood sample taken on a weekly basis until patient is assessed as no longer aspirating or until patient is discharged whichever comes first.
Secondary outcome [1] 265112 0
Patient satisfaction with treatment measured by a simple 5 point Likert scale rating factors such as taste, feel in the mouth, thirst, and coughing
Timepoint [1] 265112 0
Surveyed on a weekly basis until patient is assessed as no longer aspirating or until patient is discharged whichever comes first
Secondary outcome [2] 265113 0
Time to resolution of dysphagia measured in days
Timepoint [2] 265113 0
calculated when no longer aspirating

Eligibility
Key inclusion criteria
Inpatient in a dedicated stroke unit.
Stroke is the primary reason for admission
Able to participate in a modified barium swallow procedure
Aspirating thin fluids
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known progressive neurological condition.
History of brain tumour or brain injury.
History of head or neck cancer.
Chronic supressed immune system.
Chronic obstructive pulmonary disease.
Acute medical illness.
Receiving alternative non-oral forms of hydration or nutrition.
Aspirating smooth pureed food and/or moderately thick fluids.
On fluid restriction.
Pregnant or breast feeding.

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)
Researchers at hospital site will log on to the website, enter the details of the consented patient and be allocated a treatment group for their patient.
The patient's identifying number and hospital and their group allocation will be automatically sent to the chief researcher for the centralised patient data base.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
410
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 257426 0
Hospital
Name [1] 257426 0
Royal Adelaide Hospital
Country [1] 257426 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256658 0
University
Name [1] 256658 0
Flinders University
Address [1] 256658 0
GPO Box 2100
Adelaide SA 5001
Country [1] 256658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259446 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259446 0
Ethics committee country [1] 259446 0
Australia
Date submitted for ethics approval [1] 259446 0
Approval date [1] 259446 0
17/10/2009
Ethics approval number [1] 259446 0
090430a

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

Contacts
Principal investigator
Name 31495 0
Address 31495 0
Country 31495 0
Phone 31495 0
Fax 31495 0
Email 31495 0
Contact person for public queries
Name 14742 0
Jo Murray
Address 14742 0
207-255 Hampstead Road
Northfield SA 5085
Country 14742 0
Australia
Phone 14742 0
+61 8 82221815
Fax 14742 0
Email 14742 0
[email protected]
Contact person for scientific queries
Name 5670 0
Jo Murray
Address 5670 0
207-255 Hampstead Road
Northfield SA 5085
Country 5670 0
Australia
Phone 5670 0
+61 8 82221815
Fax 5670 0
Email 5670 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseDoes a Water Protocol Improve the Hydration and Health Status of Individuals with Thin Liquid Aspiration Following Stroke? A Randomized Controlled Trial.2016https://dx.doi.org/10.1007/s00455-016-9694-x
N.B. These documents automatically identified may not have been verified by the study sponsor.