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

University of Chile

Status: Unknown

Conditions: Tracheostomy; Covid19; Mechanical Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT04642703

65/20

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Childhood
• Pregnant women

Trial design

100 participants in 2 patient groups

COVID-19 ventilated patients subjected to tracheostomy

Description:

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

Description:

Patients supported with mechanical ventilation by 10 days or more in who an experts team of physicians decided do not perform a tracheostomy