Construction and Evaluation of a New Ultrasound Score for the Diagnosis of Swallowing Disorders in Difficult-to-wean Tracheostomised Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Swallowing disorders prediction model development
研究概览
简要总结
Swallowing Disorders (SD) is commonly observed in intensive care unit (ICU) patients.
Disruption to the upper airway by way of a tracheostomy may lead to physiological and/or biomechanical changes to the swallow, thereby increasing dysphagia risk. SD is independently associated with adverse outcomes including respiratory complications, nutritional compromise, and even death.
Experts recommend a systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening positive patients.
However, the clinical examination lacks precision. Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources and are difficult to access. No current consensus exists on how to best approach to evaluate ICU patients at risk.
In this context, US imaging has garnered increased interest for assessing swallowing disorders. Recognised for its non-invasive nature and its ability to overcome conventional constraints, this approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance the precision in targeting structures for rehabilitation.
The researchers intend to create an ultrasound diagnostic model for difficult-to-wean trahceostomised patients. Additionally, they aim to evaluate the reliability and accuracy of this model.
During an nineteen-months period, we will enrolled one hundred and nineteen difficult-to-wean tracheostomised patients at Forcilles's Hospital, Universitary Hospital of Dijon, Béthune Hospital and Bourgon Jallieu Hospital.
All patients will have a FEES evaluation. The ultrasonographer will be blinded to the patient's status and prior clinical or imaging assessments. Ultrasound assessment will focus on evaluating the movements or morphology of structures such as the tongue, laryngeal movement, or suprahyoid muscles.
A global ultrasound diagnostic model will be developed after selecting variables in logistic multivariable regression. Its sensitivity and specificity and prediction value will be estimated. The constructed model will be transformed in an easy-to-use scoring system.
The study anticipates establishing an association between ultrasound markers and swallowing disorders, aiming to enhance early detection for tailored management strategies, providing a non-invasive alternative to videofluoroscopy or FEES.
详细描述
Intensive Care Unit (ICU) stays often lead to Swallowing Disorders (SD). Physiological and biomechanical changes due to tracheostomy increase the risk of SD, which can have serious consequences for quality of life and overall health.
Experts recommend systematic bedside screening. Most algorithms include the water swallow test followed by expert comprehensive swallowing assessments of screening-positive patients. Early intervention strategies could greatly benefit, highlighting the importance of assessments identifying which specific structures require intervention and enabling a targeted rehabilitation approach. However, clinical examinations lack precision.
Complementary examinations, such as videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing (FEES), are irradiating or invasive, consume numerous resources, and are difficult to access. In this context, ultrasound imaging has garnered increased interest for assessing swallowing disorders. Recognized for its non-invasive nature and its ability to overcome conventional constraints, ultrasound holds promise in integrating morphological and dynamically swallowing-related structures evaluation. This approach, enabling both qualitative and quantitative analysis of multiple structures, would enhance precision in targeting structures for rehabilitation.
A recent study shows strong potential for an ultrasound prediction model for diagnosing swallowing disorders in outpatients. The researchers intend to create an ultrasound diagnostic model for difficult-to-wean tracheostomized patients. Additionally, they aim to evaluate the reliability and accuracy of this model. Hypothesis: The investigators hypothesize that an ultrasound predictive model is valid and reliable for diagnosing swallowing disorders in difficult-to-wean tracheostomized patients.
Main objective: The primary aim is to develop an ultrasound predictive model based on the most relevant ultrasound measurements of the aerodigestive tract.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to ICU and tracheostomised for difficult-to-wean reasons ;
- •Patients with a medical indication for nasofibroscopy ;
- •Medical prescription for physiotherapy assessment ;
- •Ultrasound operator available ;
- •Patient at least 18 years old at the time of inclusion;
- •Oral, free, informed and express patient consent
排除标准
- •Patient with total laryngectomy;
- •History of swallowing disorders prior to critical care admission;
- •History of central nervous system disorders (stroke, Parkinson's disease, etc.)
- •Patient admitted to intensive care following central neurological injury;
- •Patient with spinal cord injury above C5 ;
- •Patient's refusal to participate in the study ;
- •Known pregnancy ;
- •Cognitive impairment incompatible with understanding instructions;
- •Patient under guardianship;
- •Patient with limited care.
结局指标
主要结局
Swallowing disorders prediction model development
时间窗: The day of FEES evaluation during two hour time-frame
Selection of the most contributive ultrasound measures in the swallowing disorders diagnostic predictive model. The morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on swallowing disorder diagnosis
次要结局
- Accuracy and reliability of tongue morphologic and kinematics characteristics on swallowing disorder diagnosis(The day of FEES evaluation during two hour time-frame)
- Accuracy and reliability of hyoid movement on swallowing disorder diagnosis(The day of FEES evaluation during two hour time-frame)
- Accuracy and reliability of suprahyoid muscles characteristics on swallowing disorder diagnosis(The day of FEES evaluation during two hour time-frame)
