Dysphagia RehabilitationNCT06877897
Comparing the Assessment Accuracy Between Submental Ultrasound and Speech Therapists in Nasogastric Tube Removal
A study testing Submental ultrasound criteria and Routine swallowing function assessment of speech-language pathologist in people with Dysphagia Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia Rehabilitation
- What is being tested?
- Submental ultrasound criteria and Routine swallowing function assessment of speech-language pathologist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Study of the Differences Between Submental Ultrasonography (SUS) and Assessment by Speech-Language Pathologists (SLP) for Nasogastric Tube Removal
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.
Read more
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.
- Conditions
- Dysphagia Rehabilitation
- Being tested
- Submental ultrasound criteria, Routine swallowing function assessment of speech-language pathologist
- Keywords
- Nasogastric tube removal, Submental ultrasound, Acute dysphagia, Speech-language pathologist, hyoid bone displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submental ultrasound criteriaDiagnostic 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.
Routine swallowing function assessment of speech-language pathologistDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Submental ultrasound criteria |
| 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. Receives: Diagnostic Test: Routine swallowing function assessment of speech-language pathologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (2)
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
Measured: 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
- 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 %
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start4 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dysphagia RehabilitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, Doctor of Clinical Medicine, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877897
- Sponsor's protocol ID
- 202411050RINC
- Status last verified
- Dec 2025
- First submitted
- 4 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35565713Lee 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.
PubMed 27152268Allen 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.
PubMed 33741822Hsiao 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.
PubMed 22698507
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Differences Between Submental Ultrasonography (SUS) and Assessment by Speech-Language Pathologists (SLP) for Nasogastric Tube Removal
- ClinicalTrials.gov ID
- NCT06877897
- Acronym / sponsor ID
- 202411050RINC
- Conditions
- Dysphagia Rehabilitation
- Keywords
- Nasogastric tube removal, Submental ultrasound, Acute dysphagia, Speech-language pathologist, hyoid bone displacement
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUS group | Experimental | Diagnostic Test: Submental ultrasound criteriaThe 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. |
| SLP group | Active comparator | Diagnostic Test: Routine swallowing function assessment of speech-language pathologistThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submental ultrasound criteriaAccording 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. | Diagnostic test | SUS group |
| Routine swallowing function assessment of speech-language pathologistThe 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. | Diagnostic test | SLP group |
Primary outcome
Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal
Time frame: 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
2 secondary outcomes
Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group
Time frame: 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
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 35565713Hsu 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.
- Results publication: PubMed 27152268Lee 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.
- Results publication: PubMed 33741822Allen 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.
- Results publication: PubMed 22698507Hsiao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chin-Chung Shu, Doctor of Clinical Medicine study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submental ultrasound criteria and Routine swallowing function assessment of speech-language pathologist in people with Dysphagia Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06877897, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.