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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUS group | Experimental | 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. |
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| SLP group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Submental ultrasound criteria | Diagnostic Test | According to the submental ultrasound criteria, a maximum hyoid bone displacement of ≥1.38 cm is required in the swallowing function assessment to qualify for the oral feeding diet and tube removal training protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal | Rate of nasogastric tube removal Rate of successful completion of the tube removal training protocol | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group | Hyoid bone displacement (cm) during swallowing in submental images | From enrollment to the end of treatment at 8 weeks |
| Comparing the rate of aspiration pneumonia between the submental ultrasound group and the speech therapist group |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the background information between the submental ultrasound group and the speech therapist group | BMI in kg/m^2 Age in year Gender: male or female Indication for nasogastric tube usage | From enrollment to the end of treatment at 8 weeks |
| Comparing the GCS score between the submental ultrasound group and the speech therapist group |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Chung Shu, Doctor of Clinical Medicine | National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taipei | 100225 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35565713 | Result | 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. | |
| 27152268 | Result | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 30, 2025 |
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| Routine swallowing function assessment of speech-language pathologist | Diagnostic Test | The speech-language pathologist (SLP) assessment includes the evaluation of sensory and motor functions of the oral and facial muscles, phonation, swallowing motion, and other relevant factors. |
|
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| From enrollment to the end of treatment at 8 weeks |
Glasgow Coma Scale, score on the scale (3-15) |
| From enrollment to the end of treatment at 8 weeks |
| Comparing the Barthel index between the submental ultrasound group and the speech therapist group | Barthel Index, score on the scale, 0 -100 | From enrollment to the end of treatment at 8 weeks |
| 33741822 | Result | 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. |
| 22698507 | Result | 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. |
| Dec 28, 2025 |
| Prot_SAP_001.pdf |