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CompletedNCT05663528COVID-19Updated Jan 30, 2024

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

An observational study in COVID-19, sponsored by Universidade Federal do Rio de Janeiro. Completed at 3 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Universidade Federal do Rio de Janeiro · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • COVID-19

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Keywords

  • mechanical ventilation
  • Covid-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 350 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universidade Federal do Rio de Janeiro is the lead sponsor of 120 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
350 participants (actual)
Patient registry
No

Groups and cohorts

  • orotracheal intubation group

    Composed of Patients who were intubated after 48 hours of admission to the intensive care unit

    Procedure: orotracheal intubation

  • non-intubated group

    Composed of patients who were not intubated during their stay in the intensive care unit

Interventions

  • Procedureorotracheal intubation

    Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit

    Also known as: invasive mechanical ventilation

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What researchers measure

Primary outcomes

  1. 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.

    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

    Time frame: 3 days

Secondary outcomes

  1. time to endotracheal intubation

    It will be collected from the date of intensive care unit admission until the date of endotracheal intubation

    Time frame: 28 days

  2. length of stay in the ICU

    It will be collected from the date of intensive care unit admission until the outcome of discharge from the intensive care unit or death.

    Time frame: 6 months

  3. length of hospital

    It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.

    Time frame: 12 months

  4. mechanical ventilation days

    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

    Time frame: 6 months

  5. hospital mortality

    Mortality will be collected during the period of hospitalization

    Time frame: 12 months

07

Study locations

3 sites
  • Pedro Ernesto University Hospital
    Rio De Janeiro, 20551-030, Brazil
  • National Institute of Infectology Evandro Chagas
    Rio De Janeiro, 21040-360, Brazil
  • Clementino Fraga Filho University Hospital
    Rio De Janeiro, 21941-617, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05663528
Lead sponsor
Universidade Federal do Rio de Janeiro
Responsible party
JOSE ROBERTO LAPA E SILVA (MD PhD, Universidade Federal do Rio de Janeiro) — Principal investigator
First posted
Dec 23, 2022
Start date
Mar 1, 2023
Primary completion
Oct 31, 2023
Completion
Jan 26, 2024
Last update
Jan 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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