ANZCTR - Registration

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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]

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

Identifying Aspiration and Reducing Pneumonia in Stroke Patients

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

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]

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]