Dysphagia Rehabilitation
Conditions
Keywords
Nasogastric tube removal, Submental ultrasound, Acute dysphagia, Speech-language pathologist, hyoid bone displacement
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.
Interventions
DIAGNOSTIC_TESTSubmental ultrasound criteria
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.
DIAGNOSTIC_TESTRoutine swallowing function assessment of speech-language pathologist
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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Hyoid bone displacement (cm) during swallowing in submental images |
| 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 | * 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
| Measure | Time frame | Description |
|---|---|---|
| Comparing the background information between the submental ultrasound group and the speech therapist group | 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 |
| Comparing the GCS score between the submental ultrasound group and the speech therapist group | From enrollment to the end of treatment at 8 weeks | Glasgow Coma Scale, score on the scale (3-15) |
| Comparing the Barthel index between the submental ultrasound group and the speech therapist group | From enrollment to the end of treatment at 8 weeks | Barthel Index, score on the scale, 0 -100 |
Countries
Taiwan
Outcome results
None listed