Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients will be followed-up for 8 months after hospital discharge.

Official Title
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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.

Conditions
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Tracheal Stenosis

Intervention / Treatment
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* Diagnostic Test: Chest CT scan + baseline spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pediatric patients (< 18 years of age) Patients without a minimum of 2 months follow-up from hospital discharge

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy<br>Patients older than 18 years of age who underwent either prolonged intubation or tracheostomy will be enrolled. A minimum of 2 months follow-up from hospital discharge is required. Patients tested negative for SARS-CoV-2 will be used as a control group | Diagnostic Test: Chest CT scan + baseline spirometry<br>* Patients will perform an initial evaluation at 2 months from hospital discharge using a chest CT scan without contrast-enhancing along with a pulmonary function test using spirometry. Based on results and according to current guidelines, further follow-up or intervention will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients | Observe how many subject in the population at risk will develop tracheal stenosis during follow-up | 8 months | 
| Clinical presentation of tracheal stenosis | Describe symptoms most commonly associated with tracheal stenosis | 8 months | 
| Clinical course of tracheal stenosis | Analyse the clinical evolution of tracheal stenosis during follow-up | 8 months | 
| Outcome of tracheal stenosis | Collect data on morbidity and mortality of tracheal stenosis | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of demographic factor with a predictive and prognostic value for tracheal stenosis | Patient's characteristic (e.g. sex, age, weight and height) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival | 8 months | 
| Identification of clinical factor with a predictive and prognostic value for tracheal stenosis | Information regarding hospitalisation (e.g. personal history of diabetes, chronic obstructive pulmonary disease, previous prolonged intubation or tracheostomy) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival | 8 months | 
| Identification of radiological factor with a predictive and prognostic value for tracheal stenosis | Data collected from CT scan performed during follow-up (e.g. distance of stenosis from vocal chords, length and diameter) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival | 8 months | 
| Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis | Results obtained from pulmonary function test (e.g. forced expiratory volume at one second, forced vital capacity and peak expiratory flow rate) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival | 8 months | 
| Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis | A control-group of patient who underwent either prolonged intubation or tracheostomy without diagnosis of COVID-19 will be used as comparison to search for any difference in primary and secondary outcome | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tracheal Stenosis, COVID-19, Prolonged intubation, Tracheostomy, SARS-CoV-2