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

NCT05663528 | Completed

• 1 other identifier: 100685
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

mechanical ventilation; Covid-19

Outcome Measures

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

  3 days

Secondary Outcomes (5)

• time to endotracheal intubation

  28 days

• length of stay in the ICU

  6 months

• length of hospital

  12 months

• mechanical ventilation days

  6 months

• hospital mortality

  12 months

Study Arms (2)

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

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

Also known as: invasive mechanical ventilation

orotracheal intubation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (3)

Pedro Ernesto University Hospital

Rio de Janeiro, 20551-030, Brazil

Location

National Institute of Infectology Evandro Chagas

Rio de Janeiro, 21040-360, Brazil

Location

Clementino Fraga Filho University Hospital

Rio de Janeiro, 21941-617, Brazil

Location

Related Publications (1)

• Maia G, Martins CM, Marques V, Christovam S, Prado I, Moraes B, Rezoagli E, Foti G, Zambelli V, Cereda M, Berra L, Rocco PRM, Cruz MR, Samary CDS, Guimaraes FS, Silva PL. Derivation and external validation of predictive models for invasive mechanical ventilation in intensive care unit patients with COVID-19. Ann Intensive Care. 2024 Aug 21;14(1):129. doi: 10.1186/s13613-024-01357-4.

  PMID: 39167241 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: December 23, 2022
• Study Start: March 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: January 26, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

BR (3)