Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation
- Sponsor
- University of Chile
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 90-days mortality rate
- Last Updated
- 5 years ago
Overview
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.
Investigators
Carlos Romero, MD.
Medical Chief, Intensive Care Unit, Hospital Clínico Universidad de Chile
University of Chile
Eligibility Criteria
Inclusion Criteria
- •COVID-19 confirmed case
- •Invasive mechanical ventilation by 10 days or longer
Exclusion Criteria
- •Childhood
- •Pregnant women
Outcomes
Primary Outcomes
90-days mortality rate
Time Frame: Since mechanical ventilation onset to death or 90-days follow-up
Death occurred during the follow-up
Secondary Outcomes
- ICU length of stay(From first ICU admission to transfer at a lower complexity unit, up to 90 days)
- Time of mechanical ventilation(From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days)
- Health-care associated infections(From hospital admission to discharge, up to 90 days)
- Long-term quality of life assessed by Short Form-36 Health Survey, SF-36(One year after hospital discharge)
- Hospital length of stay(From hospital admission to discharge, up to 90 days)