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

Completed

• Conditions: COVID-19 Pneumonia; COVID-19
• Interventions: Device: noninvasive ventilation

• Registration Number: NCT05579080
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-09-13
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Status Verified: 2023-04
• Study Completion: 2023-04-06
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1319

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIV group	noninvasive ventilation	group that performed only non-invasive ventilation
HFNC group	noninvasive ventilation	group that performed only oxygen therapy by high flow nasal cannula
NIV and HFNC group	noninvasive ventilation	group that used non-invasive ventilation and oxygen therapy by high flow nasal cannula
conventional oxygen therapy group	noninvasive ventilation	group that used only conventional oxygen therapy low-flow oxygen therapy.

Primary Outcome Measures

Name	Time	Method
orotracheal intubation	during hospitalization	failure of noninvasive ventilatory therapy through the need for orotracheal intubation

Secondary Outcome Measures

Name	Time	Method
length of stay in the ICU	during hospitalization	length of stay in the ICU
length of stay in hospital	during hospitalization	length of stay in hospital
in-hospital mortality	during hospitalization	in-hospital mortality

Trial Locations

Locations (2)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio De Janeiro, Brazil

Barra D'or Hospital; 🇧🇷 Rio De Janeiro, Brazil