Comparing the Assessment Accuracy Between Submental Ultrasound and Speech Therapists in Nasogastric Tube Removal

National Taiwan University

Status: Invitation-only

Conditions: Dysphagia Rehabilitation

Treatments: Diagnostic Test: Submental ultrasound criteria; Diagnostic Test: Routine swallowing function assessment of speech-language pathologist

Study type: Interventional

Funder types: Other

Identifiers

NCT06877897

202411050RINC

Details and patient eligibility

About

This randomized controlled trial aims to compare the assessment accuracy between submental ultrasound (SUS) and speech-language pathologists (SLP) for nasogastric tube removal in post-acute dysphagia adult patients. The primary question is whether the assessment accuracy of submental ultrasound (SUS) is equivalent to or better than that of speech-language pathologists (SLP).

Participants will undergo both submental ultrasound (SUS) and speech-language pathologists (SLP) assessments and will be randomly assigned to either the SUS group or the SLP group for further evaluation.

The SUS group will follow an oral feeding and tube removal training protocol based on submental ultrasound criteria for swallowing function (maximum hyoid bone displacement ≥ 1.38 cm). The SLP group will follow similar training protocols based on the speech-language pathologist's clinical assessment.

Researchers will compare outcomes such as nasogastric tube removal rate, vital signs, basic laboratory data, hyoid bone displacement on ultrasound, choking and aspiration rates, success rates of training protocols, and Functional Oral Intake Scale (FOIS) scores to determine if SUS is a reliable assessment method for swallowing function and NG tube removal.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 and above
• Patients using a nasogastric tube
• Patients with a nasogastric tube placed due to acute conditions, such as increased oxygen demand, temporary loss of consciousness, or other illnesses causing weakness and a risk of aspiration. After treatment, there is no longer any indication for continued nasogastric tube placement.

Exclusion criteria

• Patients with impaired consciousness
• Patients with long-term nasogastric tube placement
• Patients requiring a high-concentration oxygen mask or mechanical ventilation with intubation
• Patients with significant drooling or frequent aspiration of saliva
• Patients who have undergone oral or head and neck surgery
• Patients who have received radiation therapy for the head and neck

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

SUS group

Experimental group

Description:

The SUS group follows an oral feeding diet and tube removal training protocol based on submental ultrasound criteria, with a maximum hyoid bone displacement of ≥ 1.38 cm as an indicator of swallowing function.

Treatment:

Diagnostic Test: Submental ultrasound criteria

SLP group

Active Comparator group

Description:

The SLP group follows an oral feeding diet and tube removal training protocol based on the speech-language pathologist's assessment of swallowing function, which includes evaluating sensory and motor functions of the oral and facial muscles, phonation, swallowing motion, and other relevant factors.

Treatment:

Diagnostic Test: Routine swallowing function assessment of speech-language pathologist