Clinical trial NCT05663528: ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19
Official title: ANALYSIS OF CLINICAL AND LABORATORY VARIABLES WITH PREDICTION CAPABILITY FOR INDICATION OF INVASIVE MECHANICAL VENTILATION IN PATIENTS WITH COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: mechanical ventilation
Covid-19
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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)

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.

Primary outcomes:
measure: 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.
timeFrame: 3 days
Secondary outcomes:
measure: time to endotracheal intubation
timeFrame: 28 days
measure: length of stay in the ICU
timeFrame: 6 months
measure: length of hospital
timeFrame: 12 months
measure: mechanical ventilation days
timeFrame: 6 months
measure: hospital mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Pedro Ernesto University Hospital
city: Rio De Janeiro
country: Brazil
facility: National Institute of Infectology Evandro Chagas
city: Rio De Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital
Study officials:
References: