Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000007730
Ethics application status
Approved
Date submitted
19/12/2012
Date registered
4/01/2013
Date last updated
4/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validating Cough Reflex Testing Against Instrumental Assessment Of Aspiration And Laryngeal Sensation.
Scientific title
Validating cough reflex testing in patients with dysphagia against instrumental assessment to identify those with silent aspiration
Secondary ID [1] 281733 0
nil
Universal Trial Number (UTN)
U1111-1138-0135
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysphagia 287996 0
Condition category
Condition code
Neurological 288376 288376 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective single blinded cross over correlational study. The aim of this stage is to validate the cough reflex test against previously validated instrumental measures of aspiration and penetration and laryngeal sensation (with the use of flexible naso-endoscopic assessment).

All participants will undergo 2 assessments; cough reflex testing and instrumental swallowing assessment. Both these tests are already in place at the research site for use with this patient group. Different independent researchers perform each test and will be blinded to the result of the alternate test. The tests were alternated in randomly.

Cough reflex testing takes 10 minutes approximately. Citric acid concentrations are administered for 15-seconds via facemask using PulmoMate Compressor/Nebuliser (Model 4650I, DeVilbiss Healthcare LLC, Pennsylvania, US) with a predetermined flow output of 8 litres per minute. Patients are asked to breathe normally and cough “if they feel the need to cough”. Initially a placebo dose of 0.9% NaCl is presented to coach the patient on task completion. Citric acid concentrations are administered incrementally from low to high in 1-minute intervals. A placebo dose is interdispersed between each change in citric acid dose to prevent tachyphylaxis and blunting of lower doses. Presence or absence of cough during the 15-second delivery period is documented.

VFSS assessment take place in the radiology suite. Patients are administered a standard protocol of volumes and consistencies of barium constrast agent and the procedures takes 10 minutes approximately.

FEES was performed at the patient’s bedside using a 3.2 mm diameter flexible video rhino-laryngoscope (ENF- V2, Olympus Corporation, Tokyo, Japan), an integrated light source and video processor (Olympus, OTV-SI, Olympus Corporation) and LCD Monitor (Olympus OEV203, Olympus Corporation). No topical anaesthesia was used. The endoscope was passed through the nose and positioned in the pharynx. Again a protocol involving a variety of foods and drinks are given. Aspiration is noted.
Intervention code [1] 286239 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288546 0
Validation of cough reflex testing against previously validated instrumental measures of aspiration. All assessments will be recorded and scored from the video recording by two researchers blinded to the result of the alternate test.
Timepoint [1] 288546 0
Same day- within 1 hour
Secondary outcome [1] 300437 0
not applicable
Timepoint [1] 300437 0
not applicable

Eligibility
Key inclusion criteria
Consecutive inpatients referred to speech-language pathology for initial swallowing assessment.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they were too drowsy, medically unstable to participate, were tracheotomised or where evaluation was contraindicated (e.g nasal abnormalities including epistaxis and base of skull fractures for FEES).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2011
Actual
31/10/2011
Date of last participant enrolment
Anticipated
31/01/2012
Actual
17/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286490 0
Charities/Societies/Foundations
Name [1] 286490 0
New Zealand Speech-language Therapy Association
Country [1] 286490 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
New Zealand Speech-language Therapy Assocation
Address
PO BOX 137 256, Parnell, Auckland 1151
Country
New Zealand
Secondary sponsor category [1] 285280 0
Hospital
Name [1] 285280 0
North Shore Hospital
Address [1] 285280 0
124 Shakesphere Rd, Takapuna, Auckland, 0622
Country [1] 285280 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288568 0
Northern Y Ethics Committee
Ethics committee address [1] 288568 0
Ministry of Health, No 1 The Terrace, PO BOX 5013, Wellington.6145
Ethics committee country [1] 288568 0
New Zealand
Date submitted for ethics approval [1] 288568 0
01/10/2011
Approval date [1] 288568 0
01/10/2011
Ethics approval number [1] 288568 0
NTY/11/04/038

Summary
Brief summary
In many patients with swallowing problems the ability to cough when food enters the lungs will be impaired. Currently there is no way to reliably identify patients who have no cough and therefore no way of protecting their airway if food/drink slips down the wrong way (aspiration). The data from this study will be used to develop a method of identifying these ‘at risk’ patients, and hence improving their management. The aim of this project is to validate a cough test against accepted measures of swallowing and sensation in the throat.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36718 0
Ms Anna Miles
Address 36718 0
Speech Sciences, Tamaki Campus, University of Auckland, 261 Morrin Rd, Tamaki, Auckland 1072
Country 36718 0
New Zealand
Phone 36718 0
0064211371658
Fax 36718 0
Email 36718 0
[email protected]
Contact person for public queries
Name 36719 0
Ms Anna Miles
Address 36719 0
Speech Sciences, Tamaki Campus, University of Auckland, 261 Morrin Rd, Tamaki, Auckland 1072
Country 36719 0
New Zealand
Phone 36719 0
0064211371658
Fax 36719 0
Email 36719 0
[email protected]
Contact person for scientific queries
Name 36720 0
Ms Anna Miles
Address 36720 0
Speech Sciences, Tamaki Campus, University of Auckland, 261 Morrin Rd, Tamaki, Auckland 1072
Country 36720 0
New Zealand
Phone 36720 0
0064211371658
Fax 36720 0
Email 36720 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
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