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

NCT06877897 | Enrolling By Invitation

• 1 other identifier: 202411050RINC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysphagia Rehabilitation

Keywords

Nasogastric tube removal; Submental ultrasound; Acute dysphagia; Speech-language pathologist; hyoid bone displacement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Other Outcomes (3)

• Comparing the background information between the submental ultrasound group and the speech therapist group

  From enrollment to the end of treatment at 8 weeks

• Comparing the GCS score between the submental ultrasound group and the speech therapist group

  From enrollment to the end of treatment at 8 weeks

• Comparing the Barthel index between the submental ultrasound group and the speech therapist group

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

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.

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.

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

Interventions

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.

SUS group

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.

SLP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100225, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 35565713 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.

  PMID: 27152268 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.

  PMID: 33741822 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.

  PMID: 22698507 RESULT

Study Officials

• Chin-Chung Shu, Doctor of Clinical Medicine

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 14, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)