跳至主要内容
临床试验/NCT04692779
NCT04692779已完成不适用

A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月31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
60
试验地点
1
主要终点
Oxygenation and Lung Ultrasound Score (LUS)

研究概览

简要总结

The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound.

详细描述

This is a prospective observational study of adult patients with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS who are intubated, in the prone position and receiving mechanical ventilation in the intensive care units at Rush University Medical Center. In this study design, we will prospectively enroll subjects, who fulfill eligibility criteria, to investigate the mechanism of their responses to the first three prone positioning sessions, utilizing lung ultrasound (LUS). Inclusion criteria include: adult subjects 18 years and older with a diagnosis of ARDS, endotracheally intubated and receiving assisted mechanical ventilation, meet criteria for prone positioning (ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) of ≤ 150 mm Hg with ventilator parameters of positive end-expiratory pressure (PEEP) ≥ 10 cm H2O and FiO2 of .60, and order for prone positioning. Patients will be excluded from the study if they meet the following criteria: pregnant, tracheostomy, receiving extracorporeal membrane oxygenation (ECMO), palliative care, received prone positioning more than once during intubation in an outside hospital, or receive invasive ventilation in an outside hospital for more than 72 hours. Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.

研究设计

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

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 subjects 18 years and older, diagnosis of ARDS
  • endotracheally intubated and receiving assisted mechanical ventilation
  • meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60
  • receive an order for prone positioning.

排除标准

  • Tracheostomy
  • Receiving ECMO
  • Palliative care
  • Receive prone positioning more than once during intubation in an outside hospital
  • Receive invasive ventilation in an outside hospital for more than 72 hours

结局指标

主要结局

Oxygenation and Lung Ultrasound Score (LUS)

时间窗: 10 months

Patients' responses of oxygenation and lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) to prone positioning in the first three prone positioning sessions for ARDS patients.

次要结局

  • COVID-19 ARDS vs non-COVID-19 ARDS(10 months)

研究者

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

Tyler Weiss

Clinical Education Coordinator

Rush University Medical Center

研究点 (1)

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