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

NCT04686721 | Unknown

• 1 other identifier: TS1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheal Stenosis

Keywords

Tracheal Stenosis; COVID-19; Prolonged intubation; Tracheostomy; SARS-CoV-2

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Identification of demographic factor with a predictive and prognostic value for tracheal stenosis

  8 months

• Identification of clinical factor with a predictive and prognostic value for tracheal stenosis

  8 months

• Identification of radiological factor with a predictive and prognostic value for tracheal stenosis

  8 months

• Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis

  8 months

• Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis

  8 months

Study Arms (1)

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

Interventions

Chest CT scan + baseline spirometry DIAGNOSTIC_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.

Patients at risk of developing tracheal stenosis after prolonged intubation or tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Pediatric patients (\< 18 years of age)
• Patients without a minimum of 2 months follow-up from hospital discharge

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Italy

RECRUITING

MeSH Terms

Conditions

Tracheal Stenosis; COVID-19

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Central Study Contacts

Umberto Cariboni, MD

CONTACT

+393385700988; umberto.cariboni@humanitas.it

Valentina Giatti

CONTACT

+393336766200; valentina.giatti@humanitas.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 29, 2020
• Study Start: December 20, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

IT (1)