UnknownNot Applicable

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

Italy200 participantsStarted 2020-12-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients

Timeframe: 8 months

Clinical presentation of tracheal stenosis

Timeframe: 8 months

Clinical course of tracheal stenosis

Timeframe: 8 months

Outcome of tracheal stenosis

Timeframe: 8 months

Trial details

NCT IDNCT04686721

SponsorIstituto Clinico Humanitas

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-09

Contact for this trial

Umberto Cariboni, MD

+393385700988 umberto.cariboni@humanitas.it

View on ClinicalTrials.gov More Tracheal Stenosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.