Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning
2021年11月11日 更新者:Jie Li、Rush University Medical Center
The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.
研究概览
地位
完全的
条件
详细说明
Lung ultrasound (LUS) has recently gained popularity among the imaging methods to perform bedside assessment of critically ill patients to guide clinical management.
LUS is a non-invasive and easy-to-perform procedure that provides precise data on lung aeration, lung recruitment, lung morphology, and lung perfusion.
Studies have shown that LUS is a useful tool in monitoring lung reaeration in intubated patients diagnosed with traditional ARDS undergoing prone positioning; however there are mixed findings in terms of the use of LUS in predicting potential prone positioning response.
A recent study found that the non-intubated COVID-19 patients who responded to prone positioning had more pronounced disturbances of aeration in posterior regions, however, they only investigated patients' response to the first prone positioning and the information for the patients' outcome is lacking.
In our previous study with intubated COVID-19 patients, we found that patients' response to the subsequent prone positioning had higher predictive value than the response to the first prone positioning.
Therefore, the primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.
研究类型
观察性的
注册 (实际的)
74
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult patients with acute hypoxemic respiratory failure due to COVID-19 who are admitted at Rush University Medical Center
描述
Inclusion Criteria:
- Adult subjects 18 years and older,
- Confirmed COVID-19 diagnosis
- Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 <300)
- Ordered self-prone positioning per medical team
Exclusion Criteria:
- Pregnant
- Palliative care
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SpO2/FiO2 pre prone in day 1
大体时间:pre prone in day 1
|
Patients' response of oxygenation using SpO2/FiO2
|
pre prone in day 1
|
|
SpO2/FiO2 post prone in day 1
大体时间:post prone in day 1
|
Patients' response of oxygenation using SpO2/FiO2
|
post prone in day 1
|
|
SpO2/FiO2 pre prone in day 2
大体时间:Pre prone in day 2
|
Patients' response of oxygenation using SpO2/FiO2
|
Pre prone in day 2
|
|
SpO2/FiO2 post prone in day 2
大体时间:Post prone in day 2
|
Patients' response of oxygenation using SpO2/FiO2
|
Post prone in day 2
|
|
SpO2/FiO2 pre prone in day 3
大体时间:Pre prone in day 3
|
Patients' response of oxygenation using SpO2/FiO2
|
Pre prone in day 3
|
|
SpO2/FiO2 post prone in day 3
大体时间:Post prone in day 3
|
Patients' response of oxygenation using SpO2/FiO2
|
Post prone in day 3
|
|
Lung Ultrasound Score pre prone in day 1
大体时间:Pre prone in day 1
|
Patients' response of oxygenation using Lung ultrasound score
|
Pre prone in day 1
|
|
Lung Ultrasound Score post prone in day 1
大体时间:Post prone in day 1
|
Patients' response of oxygenation using Lung ultrasound score
|
Post prone in day 1
|
|
Lung Ultrasound Score pre prone in day 2
大体时间:Pre prone in day 2
|
Patients' response of oxygenation using Lung ultrasound score
|
Pre prone in day 2
|
|
Lung Ultrasound Score post prone in day 2
大体时间:Post prone in day 2
|
Patients' response of oxygenation using Lung ultrasound score
|
Post prone in day 2
|
|
Lung Ultrasound Score pre prone in day 3
大体时间:Pre prone in day 3
|
Patients' response of oxygenation using Lung ultrasound score
|
Pre prone in day 3
|
|
Lung Ultrasound Score post prone in day 3
大体时间:Post prone in day 3
|
Patients' response of oxygenation using Lung ultrasound score
|
Post prone in day 3
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jie Li、Rush University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Weiss TT, Cerda F, Scott JB, Kaur R, Sungurlu S, Mirza SH, Alolaiwat AA, Kaur R, Augustynovich AE, Li J. Prone positioning for patients intubated for severe acute respiratory distress syndrome (ARDS) secondary to COVID-19: a retrospective observational cohort study. Br J Anaesth. 2021 Jan;126(1):48-55. doi: 10.1016/j.bja.2020.09.042. Epub 2020 Oct 10.
- Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2.
- Wang XT, Ding X, Zhang HM, Chen H, Su LX, Liu DW; Chinese Critical Ultrasound Study Group (CCUSG). Lung ultrasound can be used to predict the potential of prone positioning and assess prognosis in patients with acute respiratory distress syndrome. Crit Care. 2016 Nov 30;20(1):385. doi: 10.1186/s13054-016-1558-0.
- Avdeev SN, Nekludova GV, Trushenko NV, Tsareva NA, Yaroshetskiy AI, Kosanovic D. Lung ultrasound can predict response to the prone position in awake non-intubated patients with COVID-19 associated acute respiratory distress syndrome. Crit Care. 2021 Jan 25;25(1):35. doi: 10.1186/s13054-021-03472-1. No abstract available.
- Ibarra-Estrada M, Gamero-Rodriguez MJ, Garcia-de-Acilu M, Roca O, Sandoval-Plascencia L, Aguirre-Avalos G, Garcia-Salcido R, Aguirre-Diaz SA, Vines DL, Mirza S, Kaur R, Weiss T, Guerin C, Li J. Lung ultrasound response to awake prone positioning predicts the need for intubation in patients with COVID-19 induced acute hypoxemic respiratory failure: an observational study. Crit Care. 2022 Jun 27;26(1):189. doi: 10.1186/s13054-022-04064-3.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月21日
初级完成 (实际的)
2021年10月7日
研究完成 (实际的)
2021年10月23日
研究注册日期
首次提交
2021年4月13日
首先提交符合 QC 标准的
2021年4月21日
首次发布 (实际的)
2021年4月22日
研究记录更新
最后更新发布 (实际的)
2021年11月15日
上次提交的符合 QC 标准的更新
2021年11月11日
最后验证
2021年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.