A Retrospective and Prospective Observational, Multicentric, Case-control Clinical Study for the Evaluation of Tracheal Stenosis Among Patients With COVID-19 and Prolonged Intubation or Tracheostomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical presentation of tracheal stenosis
研究概览
简要总结
Define the actual incidence of tracheal stenosis in patients who underwent either prolonged intubation or tracheostomy and to compare incidence, clinical course and outcome between COVID-19 and non-COVID-19 patients.
详细描述
The TS1 is a national observational, multicentric, case-control clinical aiming at defining the actual incidence of tracheal stenosis in patients with COVID-19 that underwent prolonged intubation or tracheal stenosis.
Information regarding anamnestic data, demographics, smoking or alcohol habits, comorbidity, previous history of prolonged ventilation or tracheostomy, and data about intensive care unit stay and treatment will be collected before discharging patients from hospital.
All patients enrolled will perform an initial evaluation with a chest CT scan without contrast-enhancing at 2 months from hospital discharge along with pulmonary function test. If tracheal stenosis is detected, treatment according to currently available guidelines will be performed.
Patients with no signs of clinical, functional and radiological evidence of tracheal stenosis will perform a 3 and 6 months clinical follow-up from initial evaluation.
A chest CT scan with pulmonary function test will be administered if symptoms of tracheal stenosis arise during clinical follow-up. If necessary, treatment according to currently available guidelines will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •prolonged intubation, defined as the permanence of naso or oro- tracheal tube for more than 7 days
- •tracheostomy, whether surgical or percutaneous
- •minimum of 2 months follow-up from hospital discharge
- •Positivity to SARS-CoV-2 infection confirmed using PCR on either nasal swab or bronchoalveolar lavage will be not an inclusion criterion; patients tested negative will be used as a control group
排除标准
- •Pediatric patients (< 18 years of age)
- •Patients without a minimum of 2 months follow-up from hospital discharge
结局指标
主要结局
Clinical presentation of tracheal stenosis
时间窗: 8 months
Describe symptoms most commonly associated with tracheal stenosis
Clinical course of tracheal stenosis
时间窗: 8 months
Analyse the clinical evolution of tracheal stenosis during follow-up
Outcome of tracheal stenosis
时间窗: 8 months
Collect data on morbidity and mortality of tracheal stenosis
Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients
时间窗: 8 months
Observe how many subject in the population at risk will develop tracheal stenosis during follow-up
次要结局
- Identification of demographic factor with a predictive and prognostic value for tracheal stenosis(8 months)
- Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis(8 months)
- Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis(8 months)
- Identification of radiological factor with a predictive and prognostic value for tracheal stenosis(8 months)
- Identification of clinical factor with a predictive and prognostic value for tracheal stenosis(8 months)