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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; COVID-19 Pneumonia
• Intervention / Treatment: Device: noninvasive ventilation

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.

• Study Type: Observational
• Enrollment (Actual): 1319

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 21941902
    • Universidade Federal do Rio de Janeiro
  • Rio De Janeiro, Brazil
    • Barra D'or Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Pedro Silva, Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: outcome; noninvasive ventilation; COVID-19 infection; self-patient lung injury
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 52534221.5.0000.5249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No