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

NCT ID: NCT04642703

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Mechanical Ventilation Covid19 Tracheostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Childhood
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Carlos Romero, MD.

Medical Chief, Intensive Care Unit, Hospital Clínico Universidad de Chile

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Romero, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Intensive Care Unit, Hospital Clínico Universidad de Chile

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Carlos Romero, MD

Role: CONTACT

Phone: +56229788264

Email: [email protected]

Abraham Gajardo, MD

Role: CONTACT

Phone: +56229789162

Email: [email protected]

Facility Contacts

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Carlos Romero, MD

Role: primary

Abraham Gajardo, MD

Role: backup

Other Identifiers

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65/20

Identifier Type: -

Identifier Source: org_study_id