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Validating Cough Reflex Testing Against Instrumental Assessment Of Aspiration And Laryngeal Sensation.

Validating cough reflex testing in patients with dysphagia against instrumental assessment to identify those with silent aspiration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000007730
Enrollment
100
Registered
2013-01-04
Start date
2011-10-31
Completion date
2012-01-17
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 ind

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.

Sponsors

New Zealand Speech-language Therapy Assocation
Lead SponsorCharities/Societies/Foundations

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Consecutive inpatients referred to speech-language pathology for initial swallowing assessment.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026