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临床试验/NCT01324817
NCT01324817Unknown不适用

Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates

Kai Medical, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1

研究概览

简要总结

The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.

详细描述

The purpose of this study is to test two remote, Doppler radar-based sensors to measure and monitor respiratory rate. Specifically, in clinically stable neonatal patients the study aims to:

  1. Obtain respiratory effort data of neonatal patients with remote Doppler radar systems modified from a system cleared by the FDA for adult use.
  2. Determine if remote Doppler radar systems can accurately detect the respiratory rate of neonatal patients, compared with standard measurement systems.
  3. Determine if unattended Doppler radar systems, operating for 4 hours, can accurately detect the respiratory rate of neonatal patients.

研究设计

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

入排标准

年龄范围
— 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinically stable

排除标准

  • Clinically unstable
  • Hypotensive requiring pressors
  • Intubated
  • Scheduled or planned (e.g., CT scan, central line placement) procedure during the study period.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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