Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000489796
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
1/05/2013
Date last updated
4/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a clinical care protocol on patient outcomes in an acute stroke population
Scientific title
In patients with acute stroke and dysphagia, does the use of a clinical care protocol, compared to previous clinical management, result in improved patient outcomes?
Secondary ID [1] 282413 0
nil
Universal Trial Number (UTN)
U1111-1142-4401
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288994 0
Dysphagia 288995 0
Condition category
Condition code
Stroke 289340 289340 0 0
Ischaemic
Public Health 289366 289366 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with acute stroke and dysphagia who are referred for swallowing assessment will be managed under current clinical care protocols. These include a cranial nerve exam, informal assessment of cognition and communication, and cough reflex testing. If a patient passes the cough reflex test, bedside evaluation of oral intake will also be undertaken. This entire process is completed by a speech-language therapist.

Cough reflex testing involves the presentation of aerosoled citric acid solutions (0.8 and 1.2 mol/L) diluted in 0.9% sodium chloride via a facemask and nebuliser. Each presentation last for 15 seconds. Initially, a placebo (0.9% sodium chloride), is presented in order to demonstrate the test to the patient. Then, the lowest dose of citric acid is presented to the patient for 15 sec with the instructions "cough if you feel the need to cough". Presence/absence and strength of cough is documented. This process is repeated 3 times, with 30 sec between presentations to prevent tachyphylaxis. The patient is then asked to try and suppress the cough. The ability to suppress constitutes a failed response. In case of such a response, the test is repeated at 1.2 mol/L. A speech-language therapist trained in cough reflex testing administers the test.

The results of cough reflex testing rigidly dictate subsequent swallowing managment. Patients who present at least 2 out of 3 present, strong reflexive coughs and who cannot suppress at 0.8 and/or 1.2 mol/L proceed to oral trials at bedside. Patients who present with 2/3 weak or absent reflexive coughs, or who are able to suppress their cough at 1.2 mol/L remain nil by mouth, and are referred for an instrumental assessment of swallowing (videofluoroscopy).

A subgroup of patients (n = 102) will also undergo cough reflex threshold testing. The methods for this are identical to those described above, with the addition of two further concentrations of citric acid (0.6 and 1.0 mol/L). Citric acid will be presented from lowest dose to highest. The lowest concentration that elicits at least 2/3 strong reflexive coughs will be considered the patient's cough threshold, and the test will stop. A sample of oral mucosa will also be obtained in this subgroup using oral swabs. A speech-language therapist trained in these techniques will perform the test and obtain the samples.

Outcome measures will be taken upon discharge from acute stroke unit (approx 7-10 days) and at 3 months. The primary outcomes of interest are presence/absence of pneumonia, S. mitis and S. pneumonia. The relationship between pneumonia, oral bacteria, and cough reflex threshold will also be quantified.
Intervention code [1] 287047 0
Prevention
Comparator / control treatment
Historical control from a 2009 randomised control trial (McLauchlan et al. 2009, submitted for publication to Stroke journal), in which patient management did not incorporate results of cough reflex testing
Control group
Historical

Outcomes
Primary outcome [1] 289452 0
Proportion of patients with diagnosed pneumonia at the data collection points. Specifically, three or more of the following variables result in a diagnosis of pneumonia: fever (>38 degrees celcius), productive cough with purulent sputum, abnormal respiratory examination (tachypnea [>22/min], tachycardia, inspiratory crackles, bronchial breathing), abnormal chest radiograph, arterial hypoxemia (PO2 <70 mm Hg), and isolation of a relevant pathogen (positive gram stain and culture). The primary outcome will be determined by a physician.
Timepoint [1] 289452 0
Baseline, and discharge from acute stroke unit (approx 7-10 days) and 3 months post-recruitment
Primary outcome [2] 289453 0
Proportion of patients whose saliva samples show presence of S.mitis and/or S.pneumonia. Real time quantitative PCR will be used to measure the relative genomic presence of the targeted bacteria. The relative quantity of the target bacteria is determined using the analytical macro Normalization of SAS software. The underlying algorithm of this macro to determine the relative quantity is the comparative CT ‘‘delta delta Ct’’ method
Timepoint [2] 289453 0
At baseline, and at discharge from acute stroke unit (approx 7-10 days) and 3 months post-recruitment
Secondary outcome [1] 302505 0
Mortality
Timepoint [1] 302505 0
During acute hospitalisation period and at 3 months post-recruitment
Secondary outcome [2] 302506 0
Dietary restrictions as recommended by a speech-language therapist, for example, puree textures or mildly thickened fluids.
Timepoint [2] 302506 0
At discharge from acute stroke unit (approx. 7-10 days) and at 3 months post-recruitment
Secondary outcome [3] 302507 0
Route of feeding, for example, oral feeding versus nasogastric feeding versus PEG feeding.
Timepoint [3] 302507 0
At discharge from acute stroke unit (approx. 7-10 days) and at 3 months post-recruitment
Secondary outcome [4] 302508 0
History of recurrent admission/s to hospital for pneumonia, as documented in the patients' medical records as the primary cause for admission to hospital
Timepoint [4] 302508 0
At 3 months post-recruitment
Secondary outcome [5] 302509 0
Reflexive cough sensitivity as measured by cough reflex threshold testing
Timepoint [5] 302509 0
At discharge from acute stroke unit (approx. 7-10 days) and at 3 months post-recruitment

Eligibility
Key inclusion criteria
Patients with acute stroke and referred for an assessment of swallowing
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too drowsy to participate in assessment, tracheostomised, patients managed under palliative protocols

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients presenting with stroke and referred for swallowing assessment will be approached for participation. As this study seeks to audit a pre-existing clinical protocol, there will be no treatment allocation. All patients will be managed under the same protocol.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multiple logistic regressions will be used to compare outcomes from patients managed under the current clinical protocols to historical controls.

After an evaluation by the clinical advisory board for this project and hospital neurologists across NZ, a relative risk reduction of 40% was considered clinically significant and achievable for this study. On this basis, using a binomial proportion test, a sample size of 284 patients will achieve nominal 90% statistical power to detect a relative risk reduction of 40%, adjusted for 15% drop out (from the 2009 trial).

For the substudy investigating the relationship between oral bacteria and cough reflex sensitivity, a subgroup of 102 patients will achieve nominal 90% statistical power to detect a medium effect (d = 0.5), adjusted for 15% drop out.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2013
Actual
1/11/2013
Date of last participant enrolment
Anticipated
11/09/2015
Actual
11/09/2015
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
284
Accrual to date
Final
284
Recruitment outside Australia
Country [1] 5052 0
New Zealand
State/province [1] 5052 0

Funding & Sponsors
Funding source category [1] 287184 0
Self funded/Unfunded
Name [1] 287184 0
Unfunded
Country [1] 287184 0
Primary sponsor type
University
Name
University of Canterbury
Address
20 Kirkwood Ave
Ilam
Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 285948 0
None
Name [1] 285948 0
Address [1] 285948 0
Country [1] 285948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289180 0
Health and Disability Ethics Committee
Ethics committee address [1] 289180 0
Ethics committee country [1] 289180 0
New Zealand
Date submitted for ethics approval [1] 289180 0
20/05/2013
Approval date [1] 289180 0
30/07/2013
Ethics approval number [1] 289180 0
13/NTA/111

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

Contacts
Principal investigator
Name 39634 0
Miss Sarah Davies
Address 39634 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George's Medical Centre, Level 1, Leinster Chambers, 249 Papanui Road. Christchurch 8140
Country 39634 0
New Zealand
Phone 39634 0
+64 03 364 2307
Fax 39634 0
Email 39634 0
[email protected]
Contact person for public queries
Name 39635 0
Sarah Perry
Address 39635 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George's Medical Centre, Level 1, Leinster Chambers, 249 Papanui Road. Christchurch 8140
Country 39635 0
New Zealand
Phone 39635 0
+64 03 364 2307
Fax 39635 0
Email 39635 0
[email protected]
Contact person for scientific queries
Name 39636 0
Sarah Perry
Address 39636 0
The University of Canterbury Rose Centre for Stroke Recovery and Research at St George's Medical Centre, Level 1, Leinster Chambers, 249 Papanui Road. Christchurch 8140
Country 39636 0
New Zealand
Phone 39636 0
+64 03 364 2307
Fax 39636 0
Email 39636 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

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