Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05579080 |
Other study ID # |
52534221.5.0000.5249 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 1, 2021 |
Est. completion date |
April 6, 2023 |
Study information
Verified date |
April 2023 |
Source |
Universidade Federal do Rio de Janeiro |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.