Tracheal StenosisTS1NCT04686721
Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients
An observational study of Tracheal Stenosis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- Chest CT scan + baseline spirometry
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 20 Dec 2020to Oct 2021
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is addressed to an adult population (> 18 years of age) and will enroll subjects who underwent prolonged intubation or tracheostomy. Patient data collection will be divided in two cohorts: * a retrospective cohort admitted to intensive care unit (ICU) from 21/02/2020 to 30/11/2020 * a prospective cohort will include patients admitted to ICU from 01/12/2020
Who may be able to join
- 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
Who cannot join
- Pediatric patients (< 18 years of age)
- Patients without a minimum of 2 months follow-up from hospital discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Chest CT scan + baseline spirometry
- Keywords
- Tracheal Stenosis, COVID-19, Prolonged intubation, Tracheostomy, SARS-CoV-2
- Medical subject headings
- Tracheal Stenosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT scan + baseline spirometryDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Chest CT scan + baseline spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients
Observe how many subject in the population at risk will develop tracheal stenosis during follow-up
Measured: 8 months
Clinical presentation of tracheal stenosis
Describe symptoms most commonly associated with tracheal stenosis
Measured: 8 months
Clinical course of tracheal stenosis
Analyse the clinical evolution of tracheal stenosis during follow-up
Measured: 8 months
Outcome of tracheal stenosis
Collect data on morbidity and mortality of tracheal stenosis
Measured: 8 months
Secondary outcomes (5)
Identification of demographic factor with a predictive and prognostic value for tracheal stenosis
Patient's characteristic (e.g. sex, age, weight and height) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival
Measured: 8 months
Identification of clinical factor with a predictive and prognostic value for tracheal stenosis
Information regarding hospitalisation (e.g. personal history of diabetes, chronic obstructive pulmonary disease, previous prolonged intubation or tracheostomy) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival
Measured: 8 months
Identification of radiological factor with a predictive and prognostic value for tracheal stenosis
Data collected from CT scan performed during follow-up (e.g. distance of stenosis from vocal chords, length and diameter) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival
Measured: 8 months
Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis
Results obtained from pulmonary function test (e.g. forced expiratory volume at one second, forced vital capacity and peak expiratory flow rate) will be collected during follow-up to search for any statistically significant association with risk of developing tracheal stenosis or disease-free survival
Measured: 8 months
Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis
A control-group of patient who underwent either prolonged intubation or tracheostomy without diagnosis of COVID-19 will be used as comparison to search for any difference in primary and secondary outcome
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start20 Dec 2020
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686721
- Sponsor's protocol ID
- TS1
- Acronym
- TS1
- Status last verified
- Mar 2021
- First submitted
- 21 Dec 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04686721
- Acronym / sponsor ID
- TS1 / TS1
- Conditions
- Tracheal Stenosis
- Keywords
- Tracheal Stenosis, COVID-19, Prolonged intubation, Tracheostomy, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy | – | Diagnostic Test: Chest CT scan + baseline spirometryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is addressed to an adult population (> 18 years of age) and will enroll subjects who underwent prolonged intubation or tracheostomy. Patient data collection will be divided in two cohorts: * a retrospective cohort admitted to intensive care unit (ICU) from 21/02/2020 to 30/11/2020 * a prospective cohort will include patients admitted to ICU from 01/12/2020
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pediatric patients (< 18 years of age)
- Patients without a minimum of 2 months follow-up from hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest CT scan + baseline spirometryPatients 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. | Diagnostic test | Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy |
Primary outcome
Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients
Time frame: 8 months
Observe how many subject in the population at risk will develop tracheal stenosis during follow-up
Clinical presentation of tracheal stenosis
Time frame: 8 months
Describe symptoms most commonly associated with tracheal stenosis
Clinical course of tracheal stenosis
Time frame: 8 months
Analyse the clinical evolution of tracheal stenosis during follow-up
Outcome of tracheal stenosis
Time frame: 8 months
Collect data on morbidity and mortality of tracheal stenosis
5 secondary outcomes
Identification of demographic factor with a predictive and prognostic value for tracheal stenosis
Time frame: 8 months
Identification of clinical factor with a predictive and prognostic value for tracheal stenosis
Time frame: 8 months
Identification of radiological factor with a predictive and prognostic value for tracheal stenosis
Time frame: 8 months
Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis
Time frame: 8 months
Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheal Stenosis, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cariboni, MD (+393385700988, umberto.cariboni@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients (time frame: 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.