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

Istituto Clinico Humanitas

Status: Unknown

Conditions: Tracheal Stenosis

Treatments: Diagnostic Test: Chest CT scan + baseline spirometry

Study type: Observational

Funder types: Other

Identifiers

NCT04686721

TS1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy

Description:

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

Treatment:

Diagnostic Test: Chest CT scan + baseline spirometry