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NCT Number: NCT06877897

Comparing the Assessment Accuracy Between Submental Ultrasound and Speech Therapists in 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.

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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Key information

Conditions

Dysphagia Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100225, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Hyoid bone displacement (cm) during swallowing in submental images

  2. 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

    • 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 %

Other outcomes

  1. Comparing the background information between the submental ultrasound group and the speech therapist group

    Time frame: From enrollment to the end of treatment at 8 weeks

    BMI in kg/m^2 Age in year Gender: male or female Indication for nasogastric tube usage

  2. Comparing the GCS score between the submental ultrasound group and the speech therapist group

    Time frame: From enrollment to the end of treatment at 8 weeks

    Glasgow Coma Scale, score on the scale (3-15)

  3. Comparing the Barthel index between the submental ultrasound group and the speech therapist group

    Time frame: From enrollment to the end of treatment at 8 weeks

    Barthel Index, score on the scale, 0 -100

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

A Study of the Differences Between Submental Ultrasonography (SUS) and Assessment by Speech-Language Pathologists (SLP) for Nasogastric Tube Removal

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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