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

• Conditions: Mechanical Ventilation; Covid19; Tracheostomy

• Registration Number: NCT04642703
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-03
• Status Verified: 2020-11
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-23
• Last Update Submitted: 2020-11-23
• Study First Posted: 2020-11-24
• Last Update Posted: 2020-11-27
• Primary Completion: 2020-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Childhood
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
90-days mortality rate	Since mechanical ventilation onset to death or 90-days follow-up	Death occurred during the follow-up

Secondary Outcome Measures

Name	Time	Method
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.
Hospital length of stay	From hospital admission to discharge, up to 90 days	Days from hospital admission to discharge

Trial Locations

Locations (1)

Intensive Care Unit, Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Chile