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Can cervical auscultation improve the diagnosis of aspiration in children?

A randomised controlled trial comparing the effectiveness of clinical feeding evaluation versus clinical feeding evaluation with cervical auscultation in the diagnosis of aspiration in children.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000589785
Enrollment
152
Registered
2013-05-24
Start date
2012-10-01
Completion date
2014-08-30
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

Background: Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations (CFE) performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical feeding evaluation potentially reduces reliance on expensive, less readily available, radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical feeding evaluation for the detection of OPA. Aims of the study Our study investigates the utility of cervical auscultation (CA) in the assessment and diagnosis of OPA in children. The primary aim is to determine whether the clinical feeding evaluation (CFE) combined with CA increases the detection of OPA determined by MBS, compared to the clinical feeding evaluation (CFE) only. We hypothesize that the use of CA (compared to not using CA) as an adjunctive clinical tool to assess oropharyngeal dysphagia, improves the detection of OPA in children as assessed with the current gold standard, MBS.

Interventions

Children will receive either a clinical feeding examination only (CFE only) or clinical feeding examination + cervical auscultation (CFE+CA)assessment. The CFE involves a case history and mealtime observations of the child’s oral sensorimotor, feeding and swallowing skills. The examination only provides an estimation of the co-ordination and movement of food/fluids through the pharyngeal phase. This is determined through visual observation of laryngeal movement, palpation of laryngeal movemen

Children will receive either a clinical feeding examination only (CFE only) or clinical feeding examination + cervical auscultation (CFE+CA)assessment. The CFE involves a case history and mealtime observations of the child’s oral sensorimotor, feeding and swallowing skills. The examination only provides an estimation of the co-ordination and movement of food/fluids through the pharyngeal phase. This is determined through visual observation of laryngeal movement, palpation of laryngeal movement and listening to clinical features (e.g. cough, wet voice, choking, voice change). In the CFE+CA group, clinicians will be able to listen to the participant's breath and swallow sounds during the examination. A microphone is attached to the participants neck to allow access to cervical sounds generated during the swallow and breath sounds pre- and post-swallow. All children will have a modified barium swallow (MBS) procedure (dynamic x-ray of the child's swallow in the oral and pharyngeal phases) after their clinical feeding evaluation. Timing of the MBS post clinical feeding evaluation is dependent on clinical constraints at the time of assessment and will range between 24 hrs to 2 weeks. Results of the MBS will be used to compare against their clinical assessment results. Paticipants will undergo one assessment modality (CFE or CFE+CA) and one MBS only. Both assessment modalities will go for approximately 60 mins and the MBS procedure will go for approximately 30mins, with under 3 minutes of actual screening time. All procedures and assessments will be completed by a speech pathologist, specialising in paediatric dysphagia mangagement at the Royal Children's Hospital, Brisbane. For MBS procedures, a radiographer and radiologist will also be present for the study. The total duration of participant involvement in the study would be: CFE or CFE+CA (60mins) and MBS (30mins) = 90mins. No follow-up is necessary.

Sponsors

Children's Health Queensland Foundation, Queensland Children's Medical Research Institute
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

Inclusion criteria

Children aged under 18 years and who are referred for a feeding assessment or modified barium swallow study at The Royal Children's Hospital, Brisbane.

Exclusion criteria

Children deemed medically unfit to complete a clinical feeding evaluation and modifed barium swallow study as determined by the treating medical team. Children can only participate for one series of evaluations.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 22, 2026