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临床试验/NCT05579080
NCT05579080已完成不适用

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

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 1,319 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,319
试验地点
2
主要终点
orotracheal intubation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

orotracheal intubation

时间窗: during hospitalization

failure of noninvasive ventilatory therapy through the need for orotracheal intubation

次要结局

  • length of stay in the ICU(during hospitalization)
  • length of stay in hospital(during hospitalization)
  • in-hospital mortality(during hospitalization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JOSE ROBERTO LAPA E SILVA

Jose Roberto Lapa e Silva

Universidade Federal do Rio de Janeiro

研究点 (2)

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