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

Tracheal Stenosis Clinical Trial

— TS1  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04686721
• Other study ID #: TS1
• Status: Recruiting
• Start date: December 20, 2020
• Est. completion date: October 2021

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: Umberto Cariboni, MD
• Phone: +393385700988
• Email: umberto.cariboni[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Tracheal Stenosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 months
Primary	Clinical presentation of tracheal stenosis	Describe symptoms most commonly associated with tracheal stenosis	8 months
Primary	Clinical course of tracheal stenosis	Analyse the clinical evolution of tracheal stenosis during follow-up	8 months
Primary	Outcome of tracheal stenosis	Collect data on morbidity and mortality of tracheal stenosis	8 months
Secondary	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	8 months
Secondary	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	8 months
Secondary	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	8 months
Secondary	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	8 months
Secondary	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	8 months