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

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

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

Conditions
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COVID-19

Intervention / Treatment
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* Procedure: orotracheal intubation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| orotracheal intubation group<br>Composed of Patients who were intubated after 48 hours of admission to the intensive care unit | Procedure: orotracheal intubation<br>* Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit<br>* Other names: invasive mechanical ventilation;|
| non-intubated group<br>Composed of patients who were not intubated during their stay in the intensive care unit | |

What is the study measuring?
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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. | 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 |
| --- | --- | --- |
| time to endotracheal intubation | 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 | 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 | It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death. | 12 months | 
| 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 | 6 months | 
| hospital mortality | Mortality will be collected during the period of hospitalization | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, Covid-19