Clinical trial NCT04686721: Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tracheal Stenosis
Keywords: Tracheal Stenosis
COVID-19
Prolonged intubation
Tracheostomy
SARS-CoV-2
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients
timeFrame: 8 months
measure: Clinical presentation of tracheal stenosis
timeFrame: 8 months
measure: Clinical course of tracheal stenosis
timeFrame: 8 months
measure: Outcome of tracheal stenosis
timeFrame: 8 months
Secondary outcomes:
measure: Identification of demographic factor with a predictive and prognostic value for tracheal stenosis
timeFrame: 8 months
measure: Identification of clinical factor with a predictive and prognostic value for tracheal stenosis
timeFrame: 8 months
measure: Identification of radiological factor with a predictive and prognostic value for tracheal stenosis
timeFrame: 8 months
measure: Identification of instrumental factor with a predictive and prognostic value for tracheal stenosis
timeFrame: 8 months
measure: Compare COVID-19 and non-COVID-19 patients at risk of developing tracheal stenosis
timeFrame: 8 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References: