Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients
NCT ID: NCT04686721
Last Updated: 2021-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2020-12-20
2021-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients without a minimum of 2 months follow-up from hospital discharge
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Locations
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Humanitas Research Hospital
Rozzano, , Italy
Countries
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Central Contacts
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Facility Contacts
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Cariboni
Role: primary
Other Identifiers
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TS1
Identifier Type: -
Identifier Source: org_study_id
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