Clinical trial NCT04642703: Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy
Official title: Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation
Covid19
Tracheostomy
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients with respiratory failure needing mechanical ventilation for 10 days or longer

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.


Eligibility criteria: Inclusion Criteria:

* COVID-19 confirmed case
* Invasive mechanical ventilation by 10 days or longer

Exclusion Criteria:

* Childhood
* Pregnant women

Primary outcomes:
measure: 90-days mortality rate
timeFrame: Since mechanical ventilation onset to death or 90-days follow-up
Secondary outcomes:
measure: Hospital length of stay
timeFrame: From hospital admission to discharge, up to 90 days
measure: ICU length of stay
timeFrame: From first ICU admission to transfer at a lower complexity unit, up to 90 days
measure: Time of mechanical ventilation
timeFrame: From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days
measure: Health-care associated infections
timeFrame: From hospital admission to discharge, up to 90 days
measure: Long-term quality of life assessed by Short Form-36 Health Survey, SF-36
timeFrame: One year after hospital discharge
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Intensive Care Unit, Hospital Clínico Universidad de Chile
Study officials:
affiliation: Intensive Care Unit, Hospital Clínico Universidad de Chile, University of Chile
name: Carlos Romero, MD
role: PRINCIPAL_INVESTIGATOR
References: