跳至主要内容
临床试验/CTRI/2023/04/052063
CTRI/2023/04/052063进行中(未招募)不适用

Comparison of cardiac output by transthoracic echocardiography and minimally invasive device in septic shock patients

PGIMER Dr RML Hospital New Delhi1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
149
试验地点
1
主要终点
To examine the degree of agreement of the cardiac output findings of transthoracic echocardiography and minimally invasive device in septic shock patients.

研究概览

简要总结

For assessment of hemodynamic status and cardiac function, cardiac output is usually used as a surrogate parameter. Many minimally invasive and non invasive devices are used for cardiac output measurement in ICU. For minimally invasive cardiac output measurement the arterial pressure cardiac output measuring device(FloTrac) will be used in this study. It is minimally invasive and continuous cardiac output measuring device and works on arterial pressure waveform analysis. Transthoracic echocardiography is a non invasive method of measurement of cardiac output which is going to be used in this study. By this method left ventricular outflow tract diameter ( in parasternal long axis view) and velocity time integral ( in apical 5 chamber view) is derived and used for cardiac output measurement

All consecutive patients with clinical diagnosis / suspicion of septic shock at ICU admission will be enrolled. Echocardiography and 12 lead ECG will be performed to rule out aortic stenosis and atrial fibrillation. Written informed consent from first degree relatives will be taken. After connecting the patient to minimally invasive device monitor, Transthoracic Echocardiography will beperformed by investigator within the first 6 hours of ICU admission and again after every 24 hours unless the monitor get disconnected or patient develops atrial fibrillation. The study will continue for maximum of 48 hrs after first transthoracic echocardiographic examination. The cardiac output data from the minimally invasive device will be taken at the time of echocardiographic cardiac output measurement. Analysis of transthoracic cardiac output data will be done by the investigator blinded to arterial pressure cardiac output data.

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

  • Patients aged more than equal to 18 years
  • Patients with diagnosis of Septic shock
  • Patients with ICU stay of at least 24 hours
  • Patients on mechanical ventilatory support.

排除标准

  • Refusal of Consent
  • Drop out during sampling period
  • Patients having aortic stenosis and atrial fibrillation
  • Patients having Confirmative or supportive diagnosis of other causes of shock •Any contraindication to arterial line placement •Pregnancy •Age >70.

结局指标

主要结局

To examine the degree of agreement of the cardiac output findings of transthoracic echocardiography and minimally invasive device in septic shock patients.

时间窗: 12 months

次要结局

  • To identify if gender, age and body surface can affect the bias between the two devices(12 months)

研究者

发起方
PGIMER Dr RML Hospital New Delhi
申办方类型
Government medical college

研究点 (1)

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