Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000984291
Ethics application status
Approved
Date submitted
10/11/2009
Date registered
16/11/2009
Date last updated
12/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Cough testing after stroke
Scientific title
Identifying Aspiration and Reducing Pneumonia in Stroke Patients using Cough Reflex Testing
Secondary ID [1] 1129 0
Health Research Council NZ 09/658
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia in stroke patients 252159 0
Identifying Aspiration and Reducing Pneumonia in Stroke Patients 252184 0
Condition category
Condition code
Stroke 252359 252359 0 0
Ischaemic
Stroke 252360 252360 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For participants in the experimental group, the standard swallowing evaluation will be completed with the inclusion of cough reflex testing. This will occur as a one -off intervention at the time of inital assessment. Initially a placebo (0.9% Sodium choride (NaCl)) dose without citric acid will be presented to coach the participant on task completion.
The PulmoMate Compressor/Nebuliser by deVilbiss (model 4650I) with a predetermined flow output of 8 litres per minute will be turned on for a period of 15 sec.
Presence of absence of cough during the period of administration will be documented.
This test will be repeated three times with the same concentration at 30 sec intervals, with a 30 second interval between each inhalation to prevent tachyphylaxis.
Cough reflex will be identified as present when participants cough on at least two out of the three inhalations.
If patients cough readily on all three presentations of the lower concentration, the clinician will ask the patient to try to suppress the cough at this level.
Participants will be asked to “try to suppress the cough as much as they can”.
The suppressed cough threshold will be reached when participants cough at least two out of three inhalations.

For patients assigned to the experimental condition, the cough reflex test will be administered using a face mask method which was recently evaluated to establish normative data in New Zealand (NZ). These data, which have established the citric acid concentrations at which healthy individuals in two age groups (equal gender representation) produce a spontaneous cough and a suppressed cough, will be shortly available:
Monroe, M., Huckabee, M.L., Robb, M.P. (in progress). Citric-Acid Inhalation Cough Challenge – Establishing Normative Data. University of Canterbury, Swallowing Rehabilitation Research Laboratory at the Van der Veer Institute.
Intervention code [1] 241526 0
Diagnosis / Prognosis
Intervention code [2] 241527 0
Early detection / Screening
Intervention code [3] 241528 0
Prevention
Comparator / control treatment
For those in the standard evaluation group, clinical swallowing assessment will be executed as is defined by the clinical protocols of the Counties Manukau District Health Board (CMDHB) and Auckland District Health Board (ADHB) Speech and Language Therapy Departments. Management of swallowing impairment will proceed as per existing protocols based on recommendations from the clinical examination.
Control group
Active

Outcomes
Primary outcome [1] 253233 0
The primary outcome measure will be the proportion of patents who are prescribed antibiotics for suspected or confimed chest symptomotology during the 3 months post discharge
Timepoint [1] 253233 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher
Secondary outcome [1] 262189 0
Length of acute hospital stay in days
Timepoint [1] 262189 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher
Secondary outcome [2] 262190 0
% of patients with completed videofluoroscopic swallowing study or fibreoptic endoscopic evaluation of swallowing during acute admission or 3 month post acute period.
Timepoint [2] 262190 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher
Secondary outcome [3] 262191 0
Route of intake at discharge (oral vs non-oral)
Timepoint [3] 262191 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher
Secondary outcome [4] 262192 0
Diet restriction at discharge (thin vs thickened liquids; altered diet texture)
Timepoint [4] 262192 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher
Secondary outcome [5] 262193 0
% of patients with bounce-back admissions for chest infection within 3 months post discharge from acute hospitalisation.
Timepoint [5] 262193 0
Outcomes will be assessed via chart review at 3 months post discharge by a clinical researcher

Eligibility
Key inclusion criteria
All stroke patients referred for clinical or diagnostic swallowing assessment from the two hospital sites will potentially be included in the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on mechanical ventilation for respiratory support will be excluded from the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting participants will be randomly assigned to either a 1) standard evaluation group or 2) standard evaluation with inclusion of cough reflex testing. The group allocation was based on a computer-generated random numbers list. The randomisation schedule is held in the office of a researcher, remote from the study environments
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The group allocation is based on a computer-generated random numbers list.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 2321 0
New Zealand
State/province [1] 2321 0
Auckland

Funding & Sponsors
Funding source category [1] 243999 0
Government body
Name [1] 243999 0
Health Research Council New Zealand
Country [1] 243999 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Centre for Clinical Research and Effective Practice (CCRep)
Address
Centre for Clinical Research
and Effective Practice (CCRep)
PO Box 93311
Otahuhu, Auckland.
Country
New Zealand
Secondary sponsor category [1] 251351 0
None
Name [1] 251351 0
Address [1] 251351 0
Country [1] 251351 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244104 0
Northern Y Ethics Committee
Ethics committee address [1] 244104 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
Ethics committee country [1] 244104 0
New Zealand
Date submitted for ethics approval [1] 244104 0
10/11/2009
Approval date [1] 244104 0
Ethics approval number [1] 244104 0

Summary
Brief summary
We propose to evaluate the usefulness of cough testing for reducing chest infection in patients with stroke. All inpatients referred to stroke services team and referred for swallowing evaluation in a 9 month period will be approached for participation in the study. Those participants who agree to participate will be randomly assigned to either a 1) standard evaluation group or 2) standard evaluation with inclusion of cough testing. For those in the experimental group, citric acid in a mist will be inhaled through a face mask to assess cough response. These results will contribute to usual clinical decision making. Outcomes for both groups will be measured by chest infection rates by 3 months post discharge and other clinical indicators of swallowing impairment. If successful in reducing complications associated with stroke, this test can be easily implemented without significant cost or resources and consequently reduce the impact of stroke on health status and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30488 0
Address 30488 0
Country 30488 0
Phone 30488 0
Fax 30488 0
Email 30488 0
Contact person for public queries
Name 13735 0
Helen McLauchlan
Address 13735 0
Professional Leader
Speech Language Therapy
Counties Manukau District Health Board
Middlemore Hospital
Private Bag 93311, Otahuhu
Auckland 1640
Country 13735 0
New Zealand
Phone 13735 0
0064 9 2760044 x 5006
Fax 13735 0
0064 9 2704733
Email 13735 0
[email protected]
Contact person for scientific queries
Name 4663 0
Dr. Maggie -Lee Huckabee
Address 4663 0
Van der Veer Institute for Parkinson's and Brain Research
66 Stewart Street
Christchurch
New Zealand 8011
Country 4663 0
New Zealand
Phone 4663 0
64 (3) 378-6070; lab 64 (3) 378-6094;
Fax 4663 0
64 (3) 364-2760
Email 4663 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
Dimensions AICough Reflex Testing in Dysphagia Following Stroke: A Randomized Controlled Trial2013https://doi.org/10.4021/jocmr1340w
N.B. These documents automatically identified may not have been verified by the study sponsor.