NCT04686721

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tracheal Stenosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Chest CT scan + baseline spirometry	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.

Timeline

• Start date: 2020-12-20
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2020-12-29
• Last updated: 2021-03-11

Locations

1 site across 1 country: Italy