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

NCT04642703 | Unknown

• 1 other identifier: 65/20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Covid19; Tracheostomy

Outcome Measures

Primary Outcomes (1)

• 90-days mortality rate

  Death occurred during the follow-up

  Since mechanical ventilation onset to death or 90-days follow-up

Secondary Outcomes (5)

• Hospital length of stay

  From hospital admission to discharge, up to 90 days

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Childhood
• Pregnant women

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Intensive Care Unit, Hospital Clínico Universidad de Chile

Santiago, Chile

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Carlos Romero, MD

  Intensive Care Unit, Hospital Clínico Universidad de Chile, University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Romero, MD

CONTACT

+56229788264; mvenegash@hcuch.cl

Abraham Gajardo, MD

CONTACT

+56229789162; intermediomedico@hcuch.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Chief, Intensive Care Unit, Hospital Clínico Universidad de Chile

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 24, 2020
• Study Start: March 3, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2021
• Last Updated: November 27, 2020

Record last verified: 2020-11

Locations

CL (1)