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

Not Applicable

• Conditions: Dysphagia Rehabilitation

• Registration Number: NCT06877897
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The goal of this randomized controlled trial is to compare the assessment accuracy between submental ultrasound and speech-language pathologists on nasogastric tube removal in post-acute dysphagia adult patients.

The main question it aims to answer is: whether the assessment accuracy of submental ultrasound is the same or better than the assessment speech therapist. Participants will undergo submental ultrasound and speech-language pathologists' assessments, and randomly distribute to submental ultrasound (SUS) and speech-language pathologist (SLP) group for evaluation.

SUS group will enter oral feeding diet and tube removal training protocol based on the submental ultrasound criteria for swallowing function (Maximum hyoid bone displacement≧ 1.38 cm); while the SLP group will enter the above training protocols based on the speech-language pathologist's assessment.

Researchers will compare the nasogastric tube removal rate, vital signs, basic laboratory data, hyoid bone displacement on submental images, chocking and aspiration rate, the success rate of training protocols, Functional Oral Intake Scale (FOIS), etc. to see if the swallowing function and nasogastric tube removal assessment of submental ultrasound is consistent with speech-language pathologists' assessments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-04
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal	From enrollment to the end of treatment at 8 weeks	Rate of nasogastric tube removal Rate of successful completion of the tube removal training protocol

Secondary Outcome Measures

Name	Time	Method
Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group	From enrollment to the end of treatment at 8 weeks	Hyoid bone displacement (cm) during swallowing in submental images
Comparing the rate of aspiration pneumonia between the submental ultrasound group and the speech therapist group	From enrollment to the end of treatment at 8 weeks	* of patients with chocking; * of patients with aspiration pneumonia Vital signs: temperature in ℃, pulse in times/minute, respiratory rate: breaths per minute, blood pressure in mmHg, oxygen saturation in %

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan