Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy

Study Overview
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Brief Summary
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Background: Invasive mechanical ventilation (IMV) in COVID-19 patients has been associated with a high mortality rate. In this context, the utility of tracheostomy has been questioned in this group of ill patients. This study aims to compare in-hospital mortality in COVID-19 patients with and without tracheostomy due to prolonged IMV Methods: Cohort study of adult COVID-19 patients subjected to prolonged IMV. Since the first COVID-19 case (March 3, 2020) up to November 30, 2020, all adult critical patients supported with IMV by 10 days or more at the Hospital Clínico Universidad de Chile will be included in the cohort. Pregnant women and non-adult patients will be excluded. Baseline characteristics, comorbidities, laboratory data, disease severity, and ventilatory support will be retrospectively collected from clinical records. The indication of tracheostomy, as part of our standard of care, will be indicated by a team of specialists in intensive care medicine, following national guidelines, and consented to by the patient's family. The 90-days mortality rate will be the primary outcome, whereas IMV days, hospital/CU length of stay, and the frequency of healthcare-associated infections will be the secondary outcomes. Also, a follow-up interview will be performed one year after a hospital discharged in order to assess the vital status and quality of life. The mortality of patients subjected to tracheostomy will be compared with the group of patients without tracheostomy by logistic regression models. Furthermore, propensity-score methods will be performed as a complementary analysis.

Official Title
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Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation

Conditions
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Mechanical Ventilation, Covid19, Tracheostomy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 confirmed case Invasive mechanical ventilation by 10 days or longer Exclusion Criteria: Childhood Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 ventilated patients subjected to tracheostomy<br>Patients who receive percutaneous or surgical tracheostomy due to prolonged mechanical ventilation. The indication is made by an experts team and based on national guidelines | |
| COVID-19 ventilated patients without tracheostomy<br>Patients supported with mechanical ventilation by 10 days or more in who an experts team of physicians decided do not perform a tracheostomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days mortality rate | Death occurred during the follow-up | Since mechanical ventilation onset to death or 90-days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Days from hospital admission to discharge | From hospital admission to discharge, up to 90 days | 
| ICU length of stay | Days elapsed in the first ICU admission | From first ICU admission to transfer at a lower complexity unit, up to 90 days | 
| Time of mechanical ventilation | Days of invasive ventilatory support | From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days | 
| Health-care associated infections | Frequency of respiratory, urinary tract, blood stream and invasive device-related infections | From hospital admission to discharge, up to 90 days | 
| Long-term quality of life assessed by Short Form-36 Health Survey, SF-36 | Score on the the Short Form-36 Health Survey (SF-36). SF-36 is a 36-item questionary that assesses the quality of life on eight health-related aspects. It scores from 0 (maximum disability) to 100 (no disability): the lower the score the more disability. | One year after hospital discharge |