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

COVID-19 Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05663528
• Other study ID #: 100685
• Status: Completed
• Start date: March 1, 2023
• Est. completion date: January 26, 2024

Study information

• Verified date: January 2024
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 26, 2024
• Est. primary completion date: October 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho University Hospital	Rio De Janeiro
Brazil	National Institute of Infectology Evandro Chagas	Rio De Janeiro
Brazil	Pedro Ernesto University Hospital	Rio De Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to endotracheal intubation	It will be collected from the date of intensive care unit admission until the date of endotracheal intubation	28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	hospital mortality	Mortality will be collected during the period of hospitalization	12 months