Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Prevalence of Tapia's syndrome
研究概览
简要总结
Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.
Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.
详细描述
The main aim of this study was to determine the prevalence of Tapia syndrome in patients admitted to weaning unit after prolonged (>48h) orotracheal intubation in the ICU.
The secondary objectives are to:
- Describe the clinical semiology of Tapia syndrome : lingual involvement, soft palate involvement, impairment of phonation and swallowing ;
- Describe the paraclinical features of Tapia syndrome: recurrent involvement, laryngeal and lingual involvement;
- Identify factors associated with Tapia's syndrome
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Hospitalized in weaning unit
- •Duration of orotracheal intubation in the ICU greater than 48 hours;
- •Glasgow score greater than or equal to 13 ;
- •Patient at least 18 years of age at the time of inclusion;
- •Affiliation with a social security system or beneficiary of such a system ;
- •Oral, free, informed and express consent of the patient.
排除标准
- •Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer);
- •Known tumors in the vicinity of the X-nerve pathway;
- •Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis);
- •Left lung cancer with subaortic lesion;
- •History of cervical adenopathy compressing the X nerve;
- •Presence of a cervical or cerebral abscess;
- •24-hour ventilated patient;
- •Refusal of the patient or designated trusted person to participate in the study;
- •Person subject to a safeguard of justice measure ;
研究组 & 干预措施
"Non Tapia group"
Patients without Tapia's syndrome
干预措施: Diagnosis of Tapia's Syndrome (Diagnostic Test)
"Tapia group"
Patient with Tapia's syndrome
干预措施: Diagnosis of Tapia's Syndrome (Diagnostic Test)
结局指标
主要结局
Prevalence of Tapia's syndrome
时间窗: through study completion, an average of 2 years
The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.
次要结局
- Ultrasound(After initial swallowing test, maximum 1 week)
- Lingual involvment(through study completion, an average of 2 years)
- Nasofibroscopy(After initial swallowing test, maximum 1 week)
- Dysphonia(After initial swallowing test, maximum 1 week)
- Dysphagia(through study completion, an average of 2 years)
- Determining the factors associated with Tapia syndrome(The day of inclusion)
- Soft palate involvement(through study completion, an average of 2 years)