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Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients — TS1  

Tracheal Stenosis Clinical Trial

Official title:
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.

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04686721
Study type Observational [Patient Registry]
Source Istituto Clinico Humanitas
Contact Umberto Cariboni, MD
Phone +393385700988
Email umberto.cariboni@humanitas.it
Status Recruiting
Phase
Start date December 20, 2020
Completion date October 2021
View Details
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