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

January 28, 2024 updated by: JOSE ROBERTO LAPA E SILVA, Universidade Federal do Rio de Janeiro
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 20551-030
        • Pedro Ernesto University Hospital
      • Rio De Janeiro, Brazil, 21040-360
        • National Institute of Infectology Evandro Chagas
      • Rio De Janeiro, Brazil, 21941-617
        • Clementino Fraga Filho University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmation of covid-19 and with length of stay in the intensive care unit greater than 48 hours will be selected for the intubated and non-intubated groups. For the intubated group, patients who underwent endotracheal intubation after 48 hours of admission to the intensive care unit will be selected. For the non-intubated group, those patients who were not intubated during their stay in the intensive care unit will be selected.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
orotracheal intubation group
Composed of Patients who were intubated after 48 hours of admission to the intensive care unit
Procedure: orotracheal intubation
Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit
Other Names:
  • invasive mechanical ventilation
non-intubated group
Composed of patients who were not intubated during their stay in the intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mechanical ventilation days
Time Frame: 6 months
It will be collected from the date of intubation in the intensive care unit until the date of extubation or up to 48 hours off mechanical ventilation in cases of tracheostomized patients and/or until the outcome of death
6 months
hospital mortality
Time Frame: 12 months
Mortality will be collected during the period of hospitalization
12 months
time to endotracheal intubation
Time Frame: 28 days
It will be collected from the date of intensive care unit admission until the date of endotracheal intubation
28 days
length of stay in the ICU
Time Frame: 6 months
It will be collected from the date of intensive care unit admission until the outcome of discharge from the intensive care unit or death.
6 months
length of hospital
Time Frame: 12 months
It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

December 21, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100685

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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