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临床试验/NCT03582501
NCT03582501已完成不适用

Physiology of the Early Stage of Hemorrhage and Early Identification of Progression Toward Hemodynamic Instability in Humans for Validation of Current Machine Learning Models

Mayo Clinic6 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
24
试验地点
6
主要终点
Blood pressure

研究概览

简要总结

This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hypovolemia by analyzing the arterial waveforms collected during LBNP.

详细描述

Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood pressure

时间窗: One day of study visit

Arterial blood pressure prior to and during lower body negative pressure

次要结局

  • Heart rate(One day of study visit)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy B. Curry

Vice Chair, Dept of Anesthesiology and Perioperative Medicine, Primary Investigator

Mayo Clinic

研究点 (6)

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