Spot Check Noninvasive Hemoglobin (SpHb) Data Collection

Masimo Corporation1 个研究点分布在 1 个国家目标入组 2,000 人开始时间: 2022年10月25日最近更新: 2022年10月17日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Masimo Corporation
入组人数: 2,000
试验地点: 1
主要终点: Noninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL .

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this clinical study is to collect data for noninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL.

研究设计

研究类型: Observational

入排标准

年龄范围: 1.00 Month(s) 至 60.00 Year(s)（—）
性别: All

入选标准

未提供

排除标准

•â€¢ Skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, abnormalities, etc.
•â€¢ Subjects deemed not suitable for the study at the discretion of the investigator.

结局指标

主要结局

Noninvasive hemoglobin measurement (SpHb) using Masimo Pulse CO-Oximeter device and sensor in a variety subjects, including pediatric subjects, pregnant and non-pregnant adults, healthy individuals and sick patients, with hemoglobin range spanning from 3-18 g/dL .

时间窗: 10 minutes interval

次要结局

Non invasive hemoglobin(SpHb) using Masimo Pulse Co-oximeter before Invasive measurement of Hemoglobin by Blood draw with atleast 15 minutes gap between these two measurements.(Spot check analysis at an interval of 15 minutes between invasive and non-invasive measurement.)

研究者

发起方

Masimo Corporation

申办方类型

Other [Global Medical Technology Company]

研究点 (1)

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