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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642703
• Other study ID #: 65/20
• Status: Recruiting
• Start date: March 3, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2020
• Source: University of Chile
• Contact: Carlos Romero, MD
• Phone: +56229788264
• Email: mvenegash[@]hcuch.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COVID-19 confirmed case

• Invasive mechanical ventilation by 10 days or longer

Exclusion Criteria:

• Childhood

• Pregnant women

Related Conditions & MeSH terms

• Covid19
• Mechanical Ventilation
• Pneumonia
• Tracheostomy

Locations

Country	Name	City	State
Chile	Intensive Care Unit, Hospital Clínico Universidad de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-days mortality rate	Death occurred during the follow-up	Since mechanical ventilation onset to death or 90-days follow-up
Secondary	Hospital length of stay	Days from hospital admission to discharge	From hospital admission to discharge, up to 90 days
Secondary	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
Secondary	Time of mechanical ventilation	Days of invasive ventilatory support	From orotracheal intubation to mechanical ventilation extubation (weaning), up to 90 days
Secondary	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
Secondary	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