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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19 Pneumonia, COVID-19

Intervention / Treatment
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* Device: noninvasive ventilation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIV group<br>group that performed only non-invasive ventilation | Device: noninvasive ventilation<br>* The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.<br>* Other names: high flow nasal cannula;|
| HFNC group<br>group that performed only oxygen therapy by high flow nasal cannula | Device: noninvasive ventilation<br>* The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.<br>* Other names: high flow nasal cannula;|
| NIV and HFNC group<br>group that used non-invasive ventilation and oxygen therapy by high flow nasal cannula | Device: noninvasive ventilation<br>* The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.<br>* Other names: high flow nasal cannula;|
| conventional oxygen therapy group<br>group that used only conventional oxygen therapy low-flow oxygen therapy. | Device: noninvasive ventilation<br>* The medical records whose patients used some type of non-invasive ventilatory device and devices that promote oxygen supplementation will be analyzed.<br>* Other names: high flow nasal cannula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| orotracheal intubation | failure of noninvasive ventilatory therapy through the need for orotracheal intubation | during hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in the ICU | length of stay in the ICU | during hospitalization | 
| length of stay in hospital | length of stay in hospital | during hospitalization | 
| in-hospital mortality | in-hospital mortality | during hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-patient lung injury, outcome, COVID-19 infection, noninvasive ventilation