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

Mortality in Patients With Severe SARS-CoV-2 Pneumonia Who Underwent Tracheostomy Due to Prolonged Mechanical Ventilation

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.

Study Overview

• Status: Unknown
• Conditions: Covid19; Tracheostomy; Mechanical Ventilation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Carlos Romero, MD; Phone Number: +56229788264; Email: mvenegash@hcuch.cl
• Study Contact Backup: Name: Abraham Gajardo, MD; Phone Number: +56229789162; Email: intermediomedico@hcuch.cl

Study Locations

• Chile
  • Santiago, Chile
    • Recruiting
    • Intensive Care Unit, Hospital Clínico Universidad de Chile
    • Contact: Carlos Romero, MD; Phone Number: +56229788264; Email: mvenegash@hcuch.cl
    • Contact: Abraham Gajardo, MD; Phone Number: 56229789162; Email: intermediomedico@hcuch.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients with respiratory failure needing mechanical ventilation for 10 days or longer

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Childhood
• Pregnant women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
COVID-19 ventilated patients subjected to tracheostomy; 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; Patients supported with mechanical ventilation by 10 days or more in who an experts team of physicians decided do not perform a tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-days mortality rate	Death occurred during the follow-up	Since mechanical ventilation onset to death or 90-days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Days from hospital admission to discharge	From hospital admission to discharge, up to 90 days
ICU length of stay	Days elapsed in the first ICU admission	From first ICU admission to transfer at a lower complexity unit, up to 90 days
Time of mechanical ventilation	Days of invasive ventilatory support	From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days
Health-care associated infections	Frequency of respiratory, urinary tract, blood stream and invasive device-related infections	From hospital admission to discharge, up to 90 days
Long-term quality of life assessed by Short Form-36 Health Survey, SF-36	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.	One year after hospital discharge

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Carlos Romero, MD, Intensive Care Unit, Hospital Clínico Universidad de Chile, University of Chile

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 65/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No