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临床试验/NCT04385823
NCT04385823已完成不适用

Use of High Flow Nasal Cannula Oxygen During Acute Hypoxemic Respiratory Failure Related to Covid-19 and Interest of the Respiratory-oxygenation Index (ROX Index): an Observational Study

Hôpital Louis Mourier1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Changes in ROX index

研究概览

简要总结

Nasal High Flow oxygen therapy (NHF) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (AHRF). It's use has been initially limited in Covid-19 patients presenting with AHRF. The aim of the study is to describe the use of NHF in Covid-19-related AHRF and report the changes in the respiratory-oxygenation index (termed ROX index) over time in these patients.

详细描述

Nasal High Flow oxygen therapy (NHF) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (AHRF). For various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), NHF seems to have been seldomly used during the current Covid-19 epidemic in France. However, the World Health Organization, and other scientific societies list NHF among the possible options for ventilatory support.

One of the risks however, identified with NHF is to delay an intubation that would have become necessary. This delay seems to be associated with a poorer prognosis for patients.

The respiratory-oxygenation index (termed ROX index) (defined as the ratio of pulse oximetry (SpO2) over inspired fraction in oxygen (FiO2) over respiratory rate (RR); SpO2/FiO2/RR) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on NHF for AHRF. In investigators'ICU, NHF is used in patients admitted for AHRFrelated to Covid-19 and the ROX index is measured and monitoring in investigators' patients. Investigators' initial experience - consistent with feedback from other ICUs - suggests that the respiratory rate of patients with Covid-19-related AHRF is sometimes lower than would be expected given the depth of the hypoxemia. In this case, the ROX index thresholds previously identified for predicting the success or failure of NHF could be different in the case of Covid-19-associated AHRF. The purpose of this work is to describe the use of NHF in Covid-19 patients with AHRF and the evolution of the ROX score over time in patients initially treated with NHF.

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

  • Covid-19 pneumonia
  • acute hypoxemic respiratory failure
  • need for nasal high flow therapy as first line therapy
  • admission to intensive care

排除标准

  • intubation prior to NHF therapy

结局指标

主要结局

Changes in ROX index

时间窗: from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months

values of ROX index during ICU stay

次要结局

  • NHF failure(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • NHF flow(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • NHF inspired fraction in oxygen(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • oxygenation(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • respiratory status(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • prediction of intubation(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)
  • prediction of NHF success(from date of NHF initiation until date of weaning from NHF or date of intubation whichever came first, assessed up to 2 months)

研究者

发起方
Hôpital Louis Mourier
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Jean-Damien RICARD

Head Medico-surgical ICU

Hôpital Louis Mourier

研究点 (1)

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