Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients (TS1)

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheal Stenosis
• Intervention / Treatment: Diagnostic test: Chest CT scan + baseline spirometry

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Umberto Cariboni, MD; Phone Number: +393385700988; Email: umberto.cariboni@humanitas.it
• Study Contact Backup: Name: Valentina Giatti; Phone Number: +393336766200; Email: valentina.giatti@humanitas.it

Study Locations

• Italy
  • Rozzano, Italy
    • Recruiting
    • Humanitas Research Hospital
    • Contact: Cariboni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Tracheostomy; Tracheal Stenosis; Prolonged intubation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pathological Conditions, Anatomical; Tracheal Diseases; COVID-19; Constriction, Pathologic; Tracheal Stenosis
• Other Study ID Numbers: TS1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No