Swallowing assessment for neurologically impaired patient

JRCT ID: jRCT1072210136

Registered date:23/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dysphagia,gastroesophageal reflux disease,laryngopharyngeal reflux
• Date of first enrollment: 23/03/2022
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Swallowing function testing with laryngeal fiber and impedance-pH testing are routinely performed in patients with suspected severe dysphagia.
Highresolution esophageal manometry is performed to assess the pattern of dysphagia.

Outcome(s)

Primary Outcome

the usefulness of salivary pepsin and alpha amylase concentrations as an assessment of dysphagia in Neurologically Impaired Patients.

the usefulness of measuring pepsin and alpha amylase concentrations in airway secretions as an assessment of dysphagia in Neurologically Impaired Patients.

the relationship between pH impedance testing and pharyngeal pressure in high-resolution intra-oesophageal pressure testing.

• Secondary Outcome: Classification of the type of dysphagia or swallowing pneumonia based on the results of swallowing endoscopy and pH impedance testing and high-resolution intra-oesophageal pressure testing.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

In particular, Neurologically impaired patients who suspected dysphagia will be recruited by explaining the study in writing to patients admitted to pediatric surgery department of Kurume University Hospital, and patients who have given their consent will be included.

Patients who have obtained written consent to participate in the study from their surrogate.

Exclude criteria

Children with organic stenosis in the oesophagus who have difficulty inserting an impedance catheter or high-resolution oesophageal manometric catheter.

Those deemed unsuitable as research subjects by the principal investigator and research assistants.

Related Information

• Primary Sponsor: Masui Daisuke