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Clinical Trials/NCT05663528
NCT05663528
Completed
Not Applicable

ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19

Universidade Federal do Rio de Janeiro3 sites in 1 country350 target enrollmentMarch 1, 2023
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Universidade Federal do Rio de Janeiro
Enrollment
350
Locations
3
Primary Endpoint
Identify clinical and laboratory variables that may be associated with the need of endotracheal intubation in the first 72 hours of admission to the intensive care unit.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This observational and retrospective study will follow the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The aim is to verify and analyze the clinical and laboratory variables with prediction capability for indication of invasive ventilatory support in patients with COVID-19. The present study will be carried out in specific care units for patients with suspected or confirmed COVID-19. Individuals with suspected or clinical diagnosis of COVID-19, with a minimum hospital stay of 24 hours and submitted to oxygen therapy or non-invasive ventilation will be selected. Clinical and laboratory variables will be collected from the moment of admission and every 12 hours until the third day of hospitalization. The primary outcome will be rate of endotracheal intubation, while secondary outocomes will be lenght of stay in intensive care unit, and hospital, as well as mortality rate.

Detailed Description

Clinical and laboratory data will be collected from medical records from the period of the COVID-19 pandemic (February 2020 to June 2021)

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
January 26, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

JOSE ROBERTO LAPA E SILVA

MD PhD

Universidade Federal do Rio de Janeiro

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria will be individuals with confirmed diagnosis of COVID-19 by RT-PCR (reverse- transcriptase polymerase chain reaction), with minimum length of stay of 24 hours in the ICU and, patients who sign the free and clarified consent.

Exclusion Criteria

  • The exclusion criteria for participation in the study will be as follows: (1) patients under the age of 18; (2) patients with a negative laboratory test for COVID-19; (3) patients in need of emergency intubation; (4) patients who underwent previous endotracheal intubation at the same hospitalization.

Outcomes

Primary Outcomes

Identify clinical and laboratory variables that may be associated with the need of endotracheal intubation in the first 72 hours of admission to the intensive care unit.

Time Frame: 3 days

Vital signs will be collected through the cardiac monitor and clinical evaluation from the moment of admission until the third day of hospitalization, every twelve hours and full blood count and biochemistry data will be collected from patients at admission until the third day of hospitalization in the intensive care unit

Secondary Outcomes

  • length of hospital(12 months)
  • time to endotracheal intubation(28 days)
  • length of stay in the ICU(6 months)
  • mechanical ventilation days(6 months)
  • hospital mortality(12 months)

Study Sites (3)

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