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Trial registered on ANZCTR


Registration number
ACTRN12616000724471
Ethics application status
Approved
Date submitted
27/05/2016
Date registered
1/06/2016
Date last updated
3/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cough Reflex Testing following Stroke: Development of a clinical pathway
Scientific title
Cough Reflex Testing following Stroke: Development of a clinical pathway
Secondary ID [1] 289326 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298925 0
Dysphagia and aspiration pneumonia 298926 0
Condition category
Condition code
Stroke 299001 299001 0 0
Haemorrhagic
Stroke 299002 299002 0 0
Ischaemic
Respiratory 299003 299003 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Upon inclusion in the study, all participants will receive an oromotor examination assessment to evaluate the function of the muscles and structures used for swallowing, as per routine speech pathology practice.

Cough reflex testing Group:
Following the initial oromotor assessment, all participants randomly allocated to receive the cough reflex testing will undergo cough reflex testing according to the procedure that was developed by Miles et al (2013). Details of this procedure are as follows:

1. Administration procedure
Participants will be seated upright in a bed or chair. A total volume of 3ml of citric acid (which is diluted by the pharmacy department in 0.9% sodium chloride, to obtain a concentration of 0.6M)
will be administered for a maximum of 15 seconds via a facemask using a nebuliser or medical air (not oxygen) with a predetermined free-flow
\output of 7L . A sterile facemask and tubing will be provided for each participants.
The assessing speech pathologist will say to the participant, “I’m going to give you some air to breath, keep breathing normally”. The test is repeated three times with a 30-60 second rest interval between each presentation.

Cough evaluation
The speech pathologist will record the strength of each cough response using the following criteria:

Strong Two or more strong coughs
Weak Two or more weak coughs
Absent One or no cough

Criteria for positive or negative response to cough reflex testing include:

Positive result Two strong cough responses out of three trials
Positive but weak result Two weak cough responses out of three trials
Negative result Two absent responses out of the three trials


Clinical pathways following cough reflex testing
There are three pathways that will be followed, depending on the outcome of the cough reflex testing. (1) If the patient produces a positive result, the clinician will then proceed with an oral trial of food or fluid as part of the initial assessment. (2) If the patient produces positive but weak results, the clinician will proceed with oral trial of food or fluid in the intial assessment but will also refer the patient for a video-fluroscopic swallowing study (VFSS) as soon as possible (this may vary depending on when the clinic has an available appointment), as bedside indicators of aspiration may be inaccurate (i.e., patient may be silently aspirating). (3) If the patient produces a negative result, the clinician will not proceed with oral trials and will refer the patient for a VFSS prior to any oral trials, as bedside indicators of aspiration are likely to be inaccurate, with the patient having a high risk of silent aspiration.

Documentation
The cough reflex test will be documented on the patient’s medication chart, as follows: Citric Acid 3 ml 0.6M solution via nebulizer per speech pathology cough reflex procedure ‘signature’ ‘date’ ‘printed name’. The cough reflex test results will also be included speech pathology assessment notes in the electronic medical record (eMR).

2. Video-fluroscopic swallowing study
As per the aforementioned clinical pathways, patients who either fail the cough reflex testing or have a weak result will be referred for an objective instrumental assessment of swallowing via VFSS. The VFSS is a dynamic x-ray that permits the visualisation of bolus flow in relation to structural movement throughout the upper aero-digestive tract in real time. The VFSS also permits detection of the presence and timing of aspiration, i.e., entry of material below the level of the true vocal folds into the trachea, and assists in identifying the physiological and often treatable cause(s) of the aspiration. Furthermore, an VFSS allows clinicians to observe the effects of various bolus volumes, bolus textures, and compensatory strategies on swallowing physiology.

If patients are not able to access a VFSS due to unforseen mechanical breakdown, the cough reflex testing procedure will be repeated on the next day and data will be analysed separately.
Intervention code [1] 294879 0
Diagnosis / Prognosis
Comparator / control treatment
Standard practice Group
Following the initial oromotor assessment, all participants in the standard practice group (2) will undergo a clinical bedside swallowing assessment performed by the ASU speech pathologist This assessment will involve assessment, of the oral and pharyngeal phases (including assssment of cranial nerve function and palpation of hyo-laryngeal excursion) of the swallow, and a trial of appropriate diet and fluids consistencies in order to determine recommendations. If the patient is observed to not tolerate an oral diet, or if they show any indicators of aspiration pneumonia, they may then be referred for a video-fluroscopic swallowing study. Requesting a referral to VFSS will be left to the clinical judgement of the assessing speech pathologist.
Control group
Active

Outcomes
Primary outcome [1] 298465 0
- Length of stay (days) for stroke patients (time of admission and discharge from acute stroke unit) assessed using review of electronic medical records
Timepoint [1] 298465 0
Length of stay will be from admission to the hospital (including the emergency department) to discharge from the acute stroke unit.

Primary outcome [2] 298466 0
The presence of aspiration pneumonia within 3 months of the onset of a Stroke. Evidence of three or more of the following variables in the patients electronic medical record will constitute a diagnosis of aspiration pneumonia:
Fever (>38 degrees C)
Productive cough with purulent sputum
Abnormal respiratory examination [tachypnoea (>22/min), tachycardia, inspiration crackles, bronchial breathing]
Abnormal chest radiograph
Arterial hypoxemia (PO2<70mm Hg) and
Isolation of a relevant pathogen (positive gram stain and culture).
Timepoint [2] 298466 0
- Presence of confirmed aspiration pneumonia during acute stroke admission and four weeks and 3 month follow up
Primary outcome [3] 298468 0
Clinicians will be asked to complete a questionnaire which will evaluate their perceptions on cough reflex testing. It will include their attitudes towards its implementation and any barriers they perceived in using the testing. This questionnaire will contain a combination of likert scales and free form response
Timepoint [3] 298468 0
This outcome will be assessed once the data collection phase has been completed.
Secondary outcome [1] 324230 0
Number of participants (%) requiring a VFSS assessment. At the end of the data collection period the data sheets will be reviewed by the principal investigator and the number of patient requiring VFSS will be recorded.
Timepoint [1] 324230 0
Over 1 year
Secondary outcome [2] 324231 0
- The time between referral and completion of a VFSS assessment (days)
This will be assessed though a review of the electronic medical records at the end of the data collection period.
Timepoint [2] 324231 0
This will be assessed though a review of the electronic medical records at the end of the data collection period.
Secondary outcome [3] 324232 0
Level of comfort of assessment, using a 1-10 likert scale, which will also include an aphasia friendly version for patients with aphasia
Timepoint [3] 324232 0
Immediately post assessment
Secondary outcome [4] 324348 0
- Initial assessment time including time required to complete cough reflex testing. Direct time to administer the procedure will be recorded using a stopwatch and rounded to the nearest minute. Indirect time which will include sourcing referrals for VFSS, undergoing training and other related tasks will be estimated to the nearest 5 minute interval.
Timepoint [4] 324348 0
This will be recorded at the time of the initial assessment.
Secondary outcome [5] 324349 0
- Time between initial swallow assessment and referral to VFSS (days). This will be assessed though a review of the electronic medical records at the end of the data collection period.
Timepoint [5] 324349 0
This will be assessed though a review of the electronic medical records at the end of the data collection period.

Eligibility
Key inclusion criteria
Participants will be included in the study if they have been admitted to the Gold Coast University Hospital Acute Stroke Unit (ASU) with a suspected or confirmed diagnosis of cerebral vascular accident (CVA) or transient ischemic attack (TIA). Participants will be required to have their initial swallowing assessment during speech pathology working hours (8:00 - 16:30) on week days. Participants who are known to have a high intracranial pressure will be individually discussed with the treating consultant to discuss the assessment in detail and seek consent to be included in the project.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
* are under 18 years of age
* known to be pregnant
* are being treated palliatively but choose to continue to have oral intake for quality of life and comfort reasons require an initial swallowing assessment on the weekend or public holiday.
*are unable to provide informed consent to participate in the study and do not have an appropriate spokesperson to provide consent on their behalf.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were randomly assigned to either the experimental group or the control group using a computer generated list which was password protected, with the password only being know to designated randomisers who were not otherwise involved in the study.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be performed using the SPSS computer software program (version 21, IBM, USA). The independent variable will be whether or not cough reflex testing was performed), with the dependant variables being the service and patient outcomes which are largely quantitative in nature (e.g., length of stay in days, total cost of stay). For these quantitative variables, normality of data will be assessed and parametric tests employed where normality is upheld. Nonparametric statistical analyses (Wilcoxon Signed Rank Test) will be performed where normality is not upheld. Chi square tests will be used to assess the associations between categorical data (i.e., presence/absence of pneumonia) between the two groups. For patient level of comfort and clinician questionnaire data, results will be reported descriptively, with themes in clinician questionnaires free form response sections being evaluated qualitatively. The sample size was determined by a convenience sample, it was also modelled on similar research in the area of CRT that achieved statistically significant numbers with a comparable (slight smaller) sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5860 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 13301 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 293696 0
Hospital
Name [1] 293696 0
Gold Coast University Hospital - Improver Grant
Address [1] 293696 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country [1] 293696 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 292530 0
None
Name [1] 292530 0
None
Address [1] 292530 0
N/A
Country [1] 292530 0
Other collaborator category [1] 279009 0
University
Name [1] 279009 0
Griffith University
Address [1] 279009 0
Gold Coast
Country [1] 279009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295136 0
Human Research Ethics Committee Gold Coast Universiy Hospital and Health Service
Ethics committee address [1] 295136 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Ethics committee country [1] 295136 0
Australia
Date submitted for ethics approval [1] 295136 0
13/08/2014
Approval date [1] 295136 0
28/10/2014
Ethics approval number [1] 295136 0
HREC/14/QGC/152

Summary
Brief summary
The primary aim of the present project is to determine whether introducing cough reflex testing, when embedded into an established clinical pathway, will reduce the incidence of aspiration pneumonia and subsequent length of stay for acute stroke patients in comparison to patients who did not receive the testing. The secondary aims are to evaluate to the clinical feasibility of implementing cough reflex testing as part of standard initial swallowing assessment for all new stroke patients, the patient’s tolerance and clinician satisfaction.

It is hypothesised that individuals who receive the testing will demonstrate reduced rates of aspiration pneumonia and decreased average lengths of stay in comparison to patients who did not receive the testing. This hypothesis is based on the assumption that those at a high risk of silent aspiration, will be identified from the cough reflex testing prior to receiving any oral diet or fluids, thus preventing aspiration from occurring. It is also hypothesised that implementation of the cough reflex testing will result in minimal cost to the organisation, high patient tolerance and high clinician satisfaction. Therefore it is anticipated that cough reflex testing will be a clinically feasible and viable tool when implemented as standard practice for all swallowing assessment in stroke patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66258 0
Mrs Makaela Field
Address 66258 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 66258 0
Australia
Phone 66258 0
+61 7 5687 3002
Fax 66258 0
+61 7 5687 7891
Email 66258 0
makaela.field@health.qld.gov.au
Contact person for public queries
Name 66259 0
Mrs Makaela Field
Address 66259 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 66259 0
Australia
Phone 66259 0
+61 7 5687 3002
Fax 66259 0
+61 7 5687 7891
Email 66259 0
makaela.field@health.qld.gov.au
Contact person for scientific queries
Name 66260 0
Mrs Makaela Field
Address 66260 0
Gold Coast University Hospital
1 Hospital Blvd
Southport QLD 4215
Country 66260 0
Australia
Phone 66260 0
+61 7 5687 3002
Fax 66260 0
+61 7 5687 7891
Email 66260 0
makaela.field@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary