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临床试验/CTRI/2024/01/061284
CTRI/2024/01/061284已完成不适用

Utility of ultrasound and echocardiography-based parameters for successful extubation in adult patients on mechanical ventilation: a prospective observational study

Dr Prakash SShastri1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
130
试验地点
1
主要终点
To assess the association of the suggested Ultrasound and echocardiography parameters with successful tracheal extubation

研究概览

简要总结

Despite improvement in the quality of intensive care, the incidence of failed extubation is 5%–30%. Several indices have been used in the past to predict successful weaning and extubation. However, none of these indices have a good positive predictive value. Therefore, it is expected that the inclusion of ultrasound of the chest and heart would be successful in identifying the patients who will likely fail the weaning trial. Critical illness produces diaphragmatic dysfunction which can contribute to weaning failure. The inability of heart to cope with the increased load of work of breathing is also responsible for re-intubation. Therefore, we planned this study with the aim to evaluate the association of parameters derived from the ultrasound of the diaphragm, and from bedside echocardiography with successful extubation.

Critically ill adult patients who are mechanically ventilated for more than 48 hours will be screened for the study. Patients who fulfill the “readiness to wean criteria” and initiated on spontaneous breathing trial will be enrolled. We intend to enroll 130 patients in the study. Diaphragmatic Ultrasound and Echocardiography will be performed during 30 minutes of Spontaneous Breathing Trial (SBT). Primary Outcome of the study is to calculate the Area under Receiver Operating Curves (AUROC), sensitivity and specificity of Diaphragm ultrasonography and ECHO- guided parameters for assessing their association with successful tracheal extubation. Secondary outcomes include incidence of successful extubation (defined as the ability to tolerate spontaneous breathing for 48 hours without need for endotracheal re- intubation), length of ICU stay and in-hospital mortality. Receiver Operator Curve (ROC) analysis will be done to determine optimal cut off values for each parameter. The AUROC, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the parameters obtained will be calculated to analyze their association with successful extubation. This being an observational study, extubation will be carried out as per the standard protocol and the investigators will not take part in that decision.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients admitted to the ICU and on mechanical ventilation more than 48 hours and subjected to SBT during the study period will be enrolled.

排除标准

  • Post Cardiac arrest deemed not for resuscitation Failure to obtain consent.

结局指标

主要结局

To assess the association of the suggested Ultrasound and echocardiography parameters with successful tracheal extubation

时间窗: 48 hours post extubation

次要结局

  • a)The incidence of failed extubation(b) length of stay (LOS) in ICU)

研究者

发起方
Dr Prakash SShastri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Prakash S Shastri

Sir Ganga Ram Hospital

研究点 (1)

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