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临床试验/NCT02824692
NCT02824692Unknown不适用

The Incidence of Significant Clinical Findings Using Focused Ultrasound Examination for the Heart, Lungs and Abdomen in Elderly Patients Before Emergent Surgery

Rambam Health Care Campus0 个研究点目标入组 30 人开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery

研究概览

简要总结

The purpose of this study is to determine whether a focused ultrasound examination for the heart, lungs and abdomen, preformed by a trained anesthesiologist, can reveal significant clinical findings in elderly patients before emergent surgery.

详细描述

Emergent orthopedic and urological surgeries in the elderly population are characterized by high incidence of chronic diseases of the target population on one hand, and the time factor which limits the possibility to properly assess the preoperative condition on the other hand.

Therefore, anesthesiologist often perform these procedures such as hip replacement with insufficient data as compared to an elective case.

In Israel, a hip fracture must be operated on within 18 hours. This type of fracture is common to the elderly population who naturally suffer more from chronic diseases that might influence the management of anesthesia. Due to the emergent nature of the procedures involved, the patients are often operated on with only basic preoperative assessment such as ECG, chest x-ray and blood tests.

A more elaborated assessment, such as a valid echocardiography , evaluation of pleural effusion or the presence of ascites are often impossible to acquire due to inaccessibility of the echo lab (high burden, missing qualified personal ) or the availability of operation theater.

This is an observational pilot study in which the ability of a focused, bedside preoperative ultrasound examination preformed by a qualified anesthesiologist to expose significant clinical data will be evaluated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • male and female over 65 years
  • emergent operation (within 72 hours)
  • No echocardiographic examination in the past 6 months

排除标准

  • echocardiographic examination in the past 6 months
  • examination will detain surgery
  • unstable patients
  • no legal guardian, not eligible for informed consent
  • poor ultrasound image

结局指标

主要结局

The incidence of significant clinical findings using focused ultrasound examination for the heart, lungs and abdomen in elderly patients before emergent surgery

时间窗: up to 55 weeks

Clinical findings that are considered significant (eg. pneumothorax, severe aortic stenosis, pericardial effusion) will be documented and presented in a table - demonstrating their prevalence among the study population.

次要结局

  • Overall satisfaction of anesthesiologists from the clinical data provided to them(up to 55 weeks)
  • Sensitivity and specificity of a qualified anesthesiologist in the diagnosis of clinically significant findings in focused ultra sound examination for the heart, lung and abdoman(up to 55 weeks)
  • Changes in anesthetic management following the focused ultrasound examination(up to 55 weeks)

研究者

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

Dekel Lait MD

Dr.

Rambam Health Care Campus

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