Covid19, Mechanical Ventilation, Tracheostomy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University of Chile
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* COVID-19 confirmed case * Invasive mechanical ventilation by 10 days or longer
Exclusion criteria
* Childhood * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-days mortality rate | Since mechanical ventilation onset to death or 90-days follow-up | Death occurred during the follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | From hospital admission to discharge, up to 90 days | Days from hospital admission to discharge |
| ICU length of stay | From first ICU admission to transfer at a lower complexity unit, up to 90 days | Days elapsed in the first ICU admission |
| Time of mechanical ventilation | From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days | Days of invasive ventilatory support |
| Health-care associated infections | From hospital admission to discharge, up to 90 days | Frequency of respiratory, urinary tract, blood stream and invasive device-related infections |
| Long-term quality of life assessed by Short Form-36 Health Survey, SF-36 | One year after hospital discharge | 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. |
Countries
Chile
Contacts
Primary ContactCarlos Romero, MD
Backup ContactAbraham Gajardo, MD
Outcome results
None listed