Status:
UNKNOWN
Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Tracheal Stenosis
Eligibility:
All Genders
18+ years
Brief 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-CO...
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 t...
Eligibility Criteria
Inclusion
- 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
- Pediatric patients (\< 18 years of age)
- Patients without a minimum of 2 months follow-up from hospital discharge
Key Trial Info
Start Date :
December 20 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04686721
Start Date
December 20 2020
End Date
October 1 2021
Last Update
March 11 2021
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, Italy