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NCT Number: NCT05663528

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clementino Fraga Filho University Hospital, Rio de Janeiro, Brazil

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orotracheal intubation

Procedure

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

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.

    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

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. hospital mortality

    Time frame: 12 months

    Mortality will be collected during the period of hospitalization

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Acronym: COVID-19

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 23, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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