Clinical trial NCT06877897: Comparing the Assessment Accuracy Between Submental Ultrasound and Speech Therapists for Nasogastric Tube Removal
Official title: To Study the Differences Between Submental Ultrasonography (SUS) and Assessment by Speech-Language Pathologists for Assessing Nasogastric Tube Removal
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dysphagia Rehabilitation
Keywords: Nasogastric tube removal
Submental ultrasound
Acute dysphagia
Speech-language pathologist
hyoid bone displacement
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Comparing the rate of aspiration pneumonia between the submental ultrasound group and the speech therapist group
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
measure: Comparing the background information between the submental ultrasound group and the speech therapist group
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Comparing the GCS score between the submental ultrasound group and the speech therapist group
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Comparing the Barthel index between the submental ultrasound group and the speech therapist group
timeFrame: From enrollment to the end of treatment at 8 weeks
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chin-Chung Shu, Doctor of Clinical Medicine
role: STUDY_CHAIR
References:
citation: Hsu CY, Lai JN, Kung WM, Hung CH, Yip HT, Chang YC, Wei CY. Nationwide Prevalence and Outcomes of Long-Term Nasogastric Tube Placement in Adults. Nutrients. 2022 Apr 22;14(9):1748. doi: 10.3390/nu14091748.
citation: Lee YS, Lee KE, Kang Y, Yi TI, Kim JS. Usefulness of Submental Ultrasonographic Evaluation for Dysphagia Patients. Ann Rehabil Med. 2016 Apr;40(2):197-205. doi: 10.5535/arm.2016.40.2.197. Epub 2016 Apr 25.
citation: Allen JE, Clunie GM, Winiker K. Ultrasound: an emerging modality for the dysphagia assessment toolkit? Curr Opin Otolaryngol Head Neck Surg. 2021 Jun 1;29(3):213-218. doi: 10.1097/MOO.0000000000000708.
citation: Hsiao MY, Chang YC, Chen WS, Chang HY, Wang TG. Application of ultrasonography in assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. 2012 Sep;38(9):1522-8. doi: 10.1016/j.ultrasmedbio.2012.04.017. Epub 2012 Jun 12.