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Trial registered on ANZCTR


Registration number
ACTRN12613001283763
Ethics application status
Not yet submitted
Date submitted
8/11/2013
Date registered
20/11/2013
Date last updated
20/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between cough reflex testing (CRT) and silent aspiration in acute exacerbation of chronic obstructive pulmonary disease (COPD)
Scientific title
The relationship between cough reflex testing (CRT) and silent aspiration in acute exacerbation of chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 283547 0
Nil known.
Universal Trial Number (UTN)
U1111-1150-0635
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Silent aspiration 290458 0
Chronic obstructive pulmonary disease (COPD) 290459 0
Condition category
Condition code
Respiratory 290849 290849 0 0
Chronic obstructive pulmonary disease
Diet and Nutrition 290850 290850 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 290927 290927 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exploring the relationship between cough reflex testing (CRT) and silent aspiration in acute exacerbation of chronic obstructive pulmonary disease (COPD).
All participants will receive a cough reflex test post recruitment to the study.
A 2ml placebo dose of 0.9% sodium chloride without citric acid will first be administered through a face mask and nebuliser for 15 seconds, to normalise the patient to the face mask method. Should the patient cough in response to the placebo, it will be repeated twice more. Should coughing persist, the participant will be excluded from the study as either task comprehension difficulties or hypersensitivity of the cough reflex will have been demonstrated.
2ml of citric acid diluted in 0.9% saline solution to provide a 0.4mol/L concentration will be administered for up to three trials of 15 seconds each, and the participant responses to the citric acid will be subjectively rated as either absent, weak or strong. Trials will discontinue when two consistent responses are achieved. A 30 second interval will occur between trials to avoid tachyphylaxis. For the purpose of the study, a response qualifies as a cough when a two forced expulsive manoeuvres against a closed glottis are heard within one respiratory cycle as recommended by the ERS Guidelines (2007).
The cough reflex test will be repeated with all participants once deemed medically stable and/or cleared for hospital discharge.
Intervention code [1] 288245 0
Early detection / Screening
Comparator / control treatment
Within an hour, all participants will then receive a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), which involves passing a videoscope into the nasal cavity until a view of the laryngopharynx is achieved. Other equipment used will include a light source and processor, 21 inch monitor, microphone and DVD recorder for audio-visual recording. Some discomfort may be experienced during FEES; lubricating jelly will be applied to the flexible tip of the videoscope and participants will be closely managed by a skilled endoscopist. Evaluation of the oropharynx, hypopharynx and larynx and assessment of swallowing will be recorded on a FEES Assessment Form. FEES is performed at bedside, typically taking no longer than fifteen minutes.
As with cough reflex testing, FEES will be repeated for each participant at bedside, once deemed medically stable and/or cleared for hospital discharge.
Control group
Active

Outcomes
Primary outcome [1] 290847 0
Cough response to citric acid.
All participants will receive a cough reflex test (CRT) and will be instructed to “try not to cough” in order to elicit a reflexive cough, when the cough can no longer be suppressed.
Informed by ERS guidelines (2007) and previous research by Miles et al. (2013), the CRT will be administered using a PulmoMate Compressor/Nebuliser (model 4650; DeVilbiss Healthcare LLC, Pennsylvania, US) with a fixed continuous flow output of 8 litres per minute. A face mask method will be used to deliver citric acid in a single-dose from a nebuliser chamber (Hudson Micro MIST Registered Trademark Nebuliser Ref 1880), through 2.1m of soft rubbing tubing (Hudson RCI, Registered Trademark oxygen supply tubing Ref 1115) to face mask (Hudson Adult elongated see-Thru, Registered Trademark Aerosol Mask Ref 1083).
2ml of citric acid diluted in 0.9% saline solution to provide a 0.4mol/L concentrationwill be administered for up to three trials of 15 seconds each, and the participant responses to the citric acid will be subjectively rated by an SLT as either absent, weak or strong. Trials will discontinue when two consistent responses are achieved. A 30 second interval will occur between trials to avoid tachyphylaxis. For the purpose of the study, a response qualifies as a cough when a two forced expulsive manoeuvres against a closed glottis are heard within one respiratory cycle as recommended by the ERS Guidelines (2007).
Timepoint [1] 290847 0
At time of CRT.
Secondary outcome [1] 305429 0
Food and drink coloured with standard food dye for optimal visualisation during endoscopy will be administered and a rating scale known as the Penetration-Aspiration Scale (PAS; Rosenbek et al., 1996) will be used by the endoscopist and supporting clinician, to record the passage of the food bolus through the pharynx and rate participant response to any airway invasion. The highest PAS score will be documented, as well as subjective assessment of trace aspiration. Different independent researchers will perform the CRT and FEES and will be blinded to the result of the alternate test.
Timepoint [1] 305429 0
At point of assessment.

Eligibility
Key inclusion criteria
50 consecutive patients admitted to North Shore Hospital with acute exacerbation of chronic obstructive pulmonary disease (COPD) as primary diagnosis or reason for admission will be approached for participation in the study. Hospital admission lists will be screened daily to identify eligible patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deemed palliative as per medical team (identifying aspiration for these patients would unlikely change their medical management and reversibility of cough reflex is considered unlikely);
Neurological or neuromuscular impairments or progressive neurological disease e.g. stroke, bulbar and pseudobulbar palsy, Parkinson’s Disease, Multiple Sclerosis, Dementia, Motor Neurone Disease (to avoid referral bias due to known associations with dysphagia);
Endotracheal intubation within previous three months (based on Mokhlesi et al., 2002);
Previous or current tracheostomy;
Cognitive impairment which would preclude obtaining informed consent;
Current active smoking (smoking blunts cough reflex; Dicpinigaitis, 2003);
Reported clinical symptoms or diagnosis of gastro-oesophageal reflux disease (GORD; can cause reduced Lx sensitivity; Phua et al., 2005);
Known or suspected swallowing impairment unrelated to COPD;
Previous head and/or neck surgery, injury or radiation;
Current use of angiotensin-converting enzyme (ACE inhibitors; promotes cough & increases tussive effect; Morice et al., 1987);
Current use of opiates (opiates have an antitussive effect; Morice et al., 2007).
Known contraindications for FEES e.g. recent base of skull/facial fracture, recent history of severe/life-threatening epistaxis, sino-nasal and anterior skull base tumours/surgery, nasopharyngeal stenosis (guided by Royal College of Speech & Language Therapists, 2007).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be approached by the researcher and provided with a Participant Information Sheet.
Informed consent will be recorded on a Participant Consent Form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will receive both diagnostic tests.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5576 0
New Zealand
State/province [1] 5576 0
Auckland

Funding & Sponsors
Funding source category [1] 288237 0
Hospital
Name [1] 288237 0
Waitemata District Health Board
Country [1] 288237 0
New Zealand
Primary sponsor type
Hospital
Name
Waitemata District Health Board
Address
North Shore Hospital
Takapuna
Auckland
Private Bag 93503
Westlake 0622
Country
New Zealand
Secondary sponsor category [1] 286955 0
University
Name [1] 286955 0
City University London
Address [1] 286955 0
10 Northampton Square
London
EC1V 0HB
Country [1] 286955 0
United Kingdom

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290141 0
HDEC
Ethics committee address [1] 290141 0
Ethics committee country [1] 290141 0
New Zealand
Date submitted for ethics approval [1] 290141 0
18/11/2013
Approval date [1] 290141 0
Ethics approval number [1] 290141 0

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

Contacts
Principal investigator
Name 44162 0
Ms Rebecca Owen
Address 44162 0
Inpatient Allied Health North
Medicines & Health of Older People
North Shore Hospital
Takapuna
Auckland
Private Bag 93503
Westlake 0622
Country 44162 0
New Zealand
Phone 44162 0
+64 22 0250174
Fax 44162 0
Email 44162 0
Rebecca.Owen@waitematadhb.govt.nz
Contact person for public queries
Name 44163 0
Rebecca Owen
Address 44163 0
Inpatient Allied Health North
Medicines & Health of Older People
North Shore Hospital
Takapuna
Auckland
Private Bag 93503
Westlake 0622
Country 44163 0
New Zealand
Phone 44163 0
+64 22 0250174
Fax 44163 0
Email 44163 0
Rebecca.Owen@waitematadhb.govt.nz
Contact person for scientific queries
Name 44164 0
Rebecca Owen
Address 44164 0
Inpatient Allied Health North
Medicines & Health of Older People
North Shore Hospital
Takapuna
Auckland
Private Bag 93503
Westlake 0622
Country 44164 0
New Zealand
Phone 44164 0
+64 22 0250174
Fax 44164 0
Email 44164 0
Rebecca.Owen@waitematadhb.govt.nz

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
No additional documents have been identified.