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临床试验/NCT03869606
NCT03869606已完成不适用

A Trial of a Non-Invasive Cardiac Output Monitor to Determine Fluid Responsiveness in Children

Indiana University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年4月1日最近更新:
适应症

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
Cardiac Output via NICOM monitor

研究概览

简要总结

This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive leg raising, predicts changes in stroke volume, cardiac output, and blood pressure during the early stages of anesthesia. A second study will determine if early treatment of the fluid responsiveness will prevent the decline in blood pressure that accompanies general anesthesia. If the NICOM monitor permits accurate prediction in normal patients, future studies of pediatric patients undergoing major surgery would be indicated.

The investigators would like to add 25 additional patients who will have the NICOM assessments performed in the pre operative area - Pre anesthesia. General anesthesia may alter the results of the NICOM assessments. The investigators will use these 25 subjects to serve as a comparison/control group.

详细描述

Eligible patients will be identified from the surgery schedule and will be contacted by a research team member via phone ahead of their surgery date to inform them of the research study. This call will allow the research team member to answer questions and establish the subject's interest in participation. If interested, or not able to be contacted by phone, patient/family will be approached in the pre-operative area or other private hospital setting. He/she and their parent(s) will have ample time to read the consent and ask any questions regarding the study.

If the subject and his/her parent(s) agree to participate, all standard techniques for general anesthesia compatible with the particular surgical procedure will be employed. Clinical decisions concerning the subject's perioperative care will be made by the anesthesiologist of record.

Cardiac output will be measured with the NICOM cardiac output monitor. The NICOM is a non-invasive monitor using bioreactance, a proprietary technique developed by Cheetah Medical that utilizes delay time shifts to measure stroke volume when an alternating current is passed through the thorax. It requires the placement of four surface electrodes (similar to ECG electrodes) above and below the heart on each side of the patient's chest.

This study will measure cardiac output, stroke volume, and fluid responsiveness (increase in stroke volume > 10%) obtained via passive leg elevation immediately after induction of anesthesia. Adult studies have demonstrated that fifty percent of fasted patients are fluid responsive. The investigators seek to determine the incidence on children.

All decisions concerning clinical care of the subject during the perioperative period will made by the anesthesiologist of record in accordance with accepted standard of care.

研究设计

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

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 11 to no older than 17 years of age

排除标准

  • severed developmental delay,
  • orthopedic patients with leg injuries
  • injury that would prevent passive leg elevation.
  • severe aortic insufficiency,
  • severe anatomic abnormalities of the thoracic aorta
  • patients with external cardiac pacemakers. close

结局指标

主要结局

Cardiac Output via NICOM monitor

时间窗: Pre-Induction and fifteen minutes up to thirty minutes Post-Anesthesia Induction

Stroke volume x Heart Rate = Cardiac Output

次要结局

未报告次要终点

研究者

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

Andrew Stasic

Associate Professor of Anesthesia

Indiana University

研究点 (1)

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