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

Predictive Factors for Failure of Non-invasive Ventilation and High-flow Oxygen Therapy in COVID-19 Patients: A Retrospective Observational Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05579080
Enrollment
1319
Registered
2022-10-13
Start date
2021-12-01
Completion date
2023-04-06
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, COVID-19 Pneumonia

Keywords

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

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.

Detailed description

Introduction: COVID-19 is an infectious disease caused by SARS-CoV2 (severe acute respiratory syndrome by the novo coronavirus). During the progression of COVID-19 infection, some patients may require noninvasive ventilation (NIV) or high-flow nasal catheter oxygen therapy (HFNC). However, its use has proved controversial in this population. Objective: To describe, retrospectively, possible predictor variables related to the use of NIV and HFNC, in order to associate them with their failure and consequent orotracheal intubation. Materials and Methods: observational, retrospective study, according to STROBE model, from the analysis of medical records, between March 2020 and July 2021. Study approved by a co-substantiated committee of D'or research and teaching institute (CAAE: 52534221.5.0000.5249). Inclusion criteria: over 18 years of age, diagnosis of positive COVID-19, hospitalized in the ICU of a tertiary Hospital located in Rio de Janeiro, admitted between March 2020 and July 2021. Exclusion criteria: hospital stay time of less than 3 days; patients who evolved to IOT in less than 48 hours; patients whose therapy (NIV, CNAF or NIV + CNAF) lasted less than 48 hours; patients whose medical records do not have the variables for the study. Primary outcome: incidence of orotracheal intubation. Secondary outcomes: time for orotracheal intubation, length of stay in the ICU and hospital and in-hospital mortality. Statistical analysis: There was no sample calculation due to the exploratory, descriptive and retrospective nature of this study. The Mann-Whitney U test will be applied to assess differences in icu length of stay. Survival time as well as hospital length of stay until the event will be analyzed with Kaplan-Meier estimates; the log-rank test will be used for group comparison. The p-\< 0.05 will be considered statistically significant. Preliminary results: 82.6% of the medical records completed phase 1 of data collection. Of these, 64.4% used CNAF, NIV or both. 20% of the medical records passed through phase 1 completed for phase 2 collection, with characterization of the population. 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.

Interventions

DEVICEnoninvasive ventilation

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

Sponsors

Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
orotracheal intubationduring hospitalizationfailure of noninvasive ventilatory therapy through the need for orotracheal intubation

Secondary

MeasureTime frameDescription
length of stay in the ICUduring hospitalizationlength of stay in the ICU
length of stay in hospitalduring hospitalizationlength of stay in hospital
in-hospital mortalityduring hospitalizationin-hospital mortality

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026