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

NCT ID: NCT05663528

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-01-26

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)

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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orotracheal intubation group

Composed of Patients who were intubated after 48 hours of admission to the intensive care unit

orotracheal intubation

Intervention Type PROCEDURE

Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit

non-intubated group

Composed of patients who were not intubated during their stay in the intensive care unit

No interventions assigned to this group

Interventions

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orotracheal intubation

Clinical and laboratory data will be collected from patients who are intubated after 48 hours of admission to the intensive care unit

Intervention Type PROCEDURE

Other Intervention Names

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invasive mechanical ventilation

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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JOSE ROBERTO LAPA E SILVA

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pedro Ernesto University Hospital

Rio de Janeiro, , Brazil

Site Status

National Institute of Infectology Evandro Chagas

Rio de Janeiro, , Brazil

Site Status

Clementino Fraga Filho University Hospital

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 39167241 (View on PubMed)

Other Identifiers

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100685

Identifier Type: -

Identifier Source: org_study_id

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