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临床试验/CTRI/2022/06/043592
CTRI/2022/06/043592已完成不适用

ULTRASONOGRAPHIC ASSESSMENT OF LUNG AERATION AND RECURITMENT WITH USE OF PRONE POSITION IN ARDS

MANIPAL HOSPITAL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To evaluate alteration in lung density with the help of LUS and its correlation with oxygenation and outcomes in patients with ARDS.

研究概览

简要总结

INTRODUCTIONAND NEED FOR THE STUDY

Acuterespiratory distress syndrome (ARDS), characterizedby increased lung weight and loss of lung aeration, is a life-threateningcondition. According to the recently publishedliterature, significant mortality reduction in ARDS patients have been obtainedwhen prone position (PP)is utilized as an adjunct to lung protectiveventilation.

Lung Ultrasound

Lung ultrasoundhas become an attractive new tool for assessing lung status in ventilatedcritically ill patients, as suggested by the increasing number of articleswritten about it by physicians practicing in chest, intensive care or emergencymedicine. As a matter of fact, chest ultrasound can be used easily at thebedside to assess initial lung morphology in severely hypoxemic patients andcan be easily repeated, allowing the effects of therapy to be monitored. Lungultrasound (LUS) has been proposed as an alternative bedside imaging technique.Ex vivo, LUS artifacts changed with the progressive increase in lung density.In a controlled human model of lung air content variation, LUS reliablyrecorded the changes in lung aeration.

In this prospective, cross-sectional, observationalstudy we will evaluate a sample size of 50 patient admitted in ICU as moderateto severe ARDS with aim to evaluate alteration in lung densitywith the help of LUS and its correlation with oxygenation and outcomes inpatients with ARDS. Our Objective of this study will be to assess changes inlung aeration with LUS in patient with ARDS and correlate change in oxygenationin lung aeration.

LUSwill be performed according to international guidelines.We will used 1–5 MHz convex probes. All intercostal spaces of the upper andlower parts of the anterior, lateral, and posterior areas of the left and rightchest wall will be examined. (Figure 1) Four LUS exams will be performed foreach patient 1 h before and after each reversal. Data will be collected 1 hbefore PP(LUS 1), 1 h after PP (LUS 2), 1 h before the patient was turned backto the supine position (LUS 3), and 1 h after the patient was returned to thesupine position (LUS 4).

So all the datacollected will be evaluated and statistical analysis will be done by anindependent statistician.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ARDS patients with moderate to severe ARDS (fulfill the 2011 Berlin definition of ARDS).

排除标准

  • (i) Patients with massive subcutaneous emphysema or dressings in the examining area, (ii) Patients who do not resuscitate orders.

结局指标

主要结局

To evaluate alteration in lung density with the help of LUS and its correlation with oxygenation and outcomes in patients with ARDS.

时间窗: First Prone to Supine position 28 hrs

次要结局

  • To assess changes in lung aeration with LUS in patients with ARDS(During Supine and Prone Position)
  • Correlate change in oxygenation with changes in lung aeration.(24-28 hrs)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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