Development and Assessment of a New Ultrasound Score to Diagnose Swallowing Disorders in at Risk-out-patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Swallowing ultrasound predictive model development
研究概览
简要总结
Swallowing disorders management requires an accurate recognition of implicated anatomical structures and pathways. The usual clinical assessment of swallowing disorders lacks reliability and accuracy. The gold standard remains the videofluoroscopy. However, this imaging technique lacks reliability and standardisation. Moreover, videofluoroscopy is not easily available, time and material consuming and exposes patients to ionisation. Ultrasound imaging, which can be performed at the patient's bedside, is a non-invasive tool. It allows the evaluation of the main structures involved in all the swallowing pathways and may be a promising tool to assess the swallowing disorders. An ultrasound predictive model has never been developed to diagnose swallowing disorders.
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders, and assess its reliability and accuracy.
One hundred outpatients at risk of swallowing disorders (neck cancer, neurological diseases, previous ICU stay) will be enrolled in the Dysphagia Diagnostic Unit at the Forcilles' Hospital, during a 2-year period.
All patients will undergo a clinical examination by a speech-language therapist, and a videofluoroscopy imaging in order to diagnose swallowing disorders. Then, an ultrasound examination will be performed by the ultrasonographer. The ultrasonographer will be blinded from the patient's status and previous clinical and imaging assessments. Severity of the swallowing disorder will be assessed by the Dysphagia Outcome and Severity Scale.
The tongue kinetics and thickness, the laryngeal movement and the suprahyoid muscles thickness and echogenicity will be assessed by ultrasonography.
Inter- and intra-reliability of ultrasound examination will be calculated. The threshold of each ultrasound measurement allowing the swallowing disorders will be estimated using the ROC curve analysis. Sensitivity and specificity of each ultrasound measurement will be estimated. A global ultrasound predictive model will be developed after selecting variables in logistic multivariable regression. Diagnostic accuracy of the global predictive model will also be assessed.
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic. As ultrasonography is easy-to-perform, rapidly available, non-invasive and inexpensive, it may be a valuable alternative to videofluoroscopy in swallowing disorder diagnostic.
详细描述
Swallowing disorders management requires an accurate recognition of implicated anatomical structures and pathways. The usual clinical assessment of swallowing disorders lack of reliability and accuracy. The gold standard remains the videofluoroscopy. However, this imaging technique lacks reliability and standardisation. Moreover, videofluoroscopy not easily available is time and material consuming and implies ionisation. Ultrasound imaging, which can be performed at the patient's bedside, is a non-invasive tool. It allows the evaluation of the main structures involved in all the swallowing pathways and may be a promising tool for swallowing disorders assessment.
The investigators aim to develop an ultrasound predictive model to diagnose swallowing disorders, and assess its reliability and accuracy.
The investigators hope a high reliability and accuracy of the ultrasound predictive model in the swallowing disorders diagnostic. As ultrasonography is easy-to-perform, rapidly available, non-invasive and inexpensive, it may be a valuable alternative to videofluoroscopy in swallowing disorders diagnostic.
- Hypothesis The investigators hypothesise that a new ultrasound predictive model is valid and reliable to diagnose swallowing disorder.
- Objectives
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients refered to swallowing assessment at the Forcilles' hospital;
- •Medical indication to perform a videofluoroscopy;
- •Ultrasonographer available;
- •Age > 18 years old;
- •Membership of a social insurance sheme;
- •Patient provides consent.
排除标准
- •Previous laryngectomy surgery;
- •Refusal to participate in the study;
- •Known pregnancy;
- •Person subject to judicial health protection;
- •Cognitive disorder incompatible with the understanding of instructions;
- •Patient under guardianship or curatorship.
结局指标
主要结局
Swallowing ultrasound predictive model development
时间窗: Through study completion, an average of 2 years
Selection of the most contributive ultrasound measures in the swallowing disorders diagnostic predictive model.
次要结局
- Accuracy and reliability of ultrasound measure of the tongue kinetics(Through study completion, an average of 2 years)
- Inter and intra-operator reliability assessment of the swallowing ultrasound assessment(Through tweenty first inclusion completion, an average of 15 weeks)
- Accuracy and reliability of ultrasound measure of the digastric muscles(Through study completion, an average of 2 years)
- Accuracy and reliability of ultrasound measure of hyoid bone movement(Through study completion, an average of 2 years)
- Accuracy and reliability of ultrasound assessment of the geniohyoid muscle(Through study completion, an average of 2 years)