Predictive Factors for Failure of Non-invasive Support Ventilation in Patients With COVID-19: A Retrospective Study.

NCT05579080 | Completed

• 1 other identifier: 52534221.5.0000.5249
• Study Type: observational
• Target: 1,319
• Locations: 1 country
• Sites: 2

Brief Summary

During the progression of COVID-19, some patients may require noninvasive ventilation (NIV) or high-flow nasal catheter (CNAF) oxygen therapy. The objective of the study is describe, retrospectively, possible predictor variables related to the use of NIV and CNAF, in order to associate them with their failure and consequent orotracheal intubation, through a retrospective analysis of a tertiary hospital in Rio de Janeiro. The primary and second outcomes are incidence of orotracheal intubation; time for OIT, length of stay in the ICU and hospital, and in-hospital mortality. The preliminary results shows that the absence of heart disease and dementia, as well as the acute onset of symptoms (less than or equal to 10 days) and age (between 40 and 79 years) showed a statistically significant trend.

Conditions

COVID-19 Pneumonia; COVID-19

Keywords

self-patient lung injury; outcome; COVID-19 infection; noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• orotracheal intubation

  failure of noninvasive ventilatory therapy through the need for orotracheal intubation

  during hospitalization

Secondary Outcomes (3)

• length of stay in the ICU

  during hospitalization

• length of stay in hospital

  during hospitalization

• in-hospital mortality

  during hospitalization

Study Arms (4)

NIV group

group that performed only non-invasive ventilation

Device: noninvasive ventilation

HFNC group

group that performed only oxygen therapy by high flow nasal cannula

Device: noninvasive ventilation

NIV and HFNC group

group that used non-invasive ventilation and oxygen therapy by high flow nasal cannula

Device: noninvasive ventilation

conventional oxygen therapy group

group that used only conventional oxygen therapy low-flow oxygen therapy.

Device: noninvasive ventilation

Interventions

noninvasive ventilation DEVICE

The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.

Also known as: conventional oxygen therapy, high flow nasal cannula

HFNC group; NIV and HFNC group; NIV group; conventional oxygen therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, 18 years of age and older, admitted to the ICU with COVID-19 confirmed by positive RT-PCR or chest CT suggestive of pneumonia caused by COVID-19, admitted between March 2020 and July 2021, who progressed to respiratory failure, requiring some ventilatory support or supplemental oxygen therapy

You may qualify if:

• Adult patients, 18 years of age and older,
• admitted to the ICU with COVID-19 confirmed by positive reverse transcriptase reaction followed by the polymerase chain reaction or chest CT suggestive of pneumonia caused by COVID-19
• admitted between March 2020 and July 2021.

You may not qualify if:

• Estimated length of hospital stay less than 3 days;
• Patients who progressed to OTI in less than 48 hours of hospital stay;
• Patients whose use of NIV and/or HFNC lasted less than 48 hours;
• Patients whose medical records lack predictive and outcome variables.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (2)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941902, Brazil

Location

Barra D'or Hospital

Rio de Janeiro, Brazil

Location

Related Publications (1)

• da Cruz AP, Martins G, Martins CM, Marques V, Christovam S, Battaglini D, Robba C, Pelosi P, Rocco PRM, Cruz FF, Dos Santos Samary C, Silva PL. Comparison between high-flow nasal oxygen (HFNO) alternated with non-invasive ventilation (NIV) and HFNO and NIV alone in patients with COVID-19: a retrospective cohort study. Eur J Med Res. 2024 Apr 22;29(1):248. doi: 10.1186/s40001-024-01826-3.

  PMID: 38649940 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Noninvasive Ventilation

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Pedro Silva

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jose Roberto Lapa e Silva

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: December 1, 2021
• Primary Completion: September 13, 2022
• Study Completion: April 6, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

BR (2)