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Набор по приглашению NCT06877897

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

Без фазы С лечением Dysphagia Rehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Submental ultrasound criteria, Routine swallowing function assessment of speech-language pathologist.
Кому может быть актуально
Состояния в реестре: Dysphagia Rehabilitation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Диагностический тест Submental 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.
  • Диагностический тест Routine 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.

Первичные конечные точки

  • Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (2)
  • Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group [Срок оценки: 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 [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Скрининг

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Публикации

  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06877897 · 202411050RINC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗