CTRI/2019/06/019933已完成不适用
Validation of B.O.L.T Body Life Tracker Device accuracy in measuring Blood Oxygen saturation (SpO2) and Pulse Rate in non-motion controlled desaturation environment in healthy adults as per EVS-EN ISO 80601-2-61:2011.
AmZetta Technologies Pvt Ltd1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The values obtained from the test device will be compared by the test values obtained by the co-oximeter and statistical analysis will be done as per the EVS-EN ISO 80601-2-61:2011.
研究概览
简要总结
The SpO2 probe is designed for non-invasive spot-check of arterial oxygen saturation (SpO2) and pulse rate for the intended operator (patient/user) in a home, hospital or clinical environment.
The purpose of trial is to determine the accuracy of the test device as per the specified standard.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject is willing to give written informed consent for participation in the study.
- •Healthy Male or Female, between 18-45 years of age.
- •Subject willing to undergo controlled desaturation.
- •Subject in a general healthy state with no evidence of ongoing medication and ongoing illness that effect the participation into the study.
- •At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger will be recruited into the study.
排除标准
- •Subject has any deformity at sensor site location
- •Pregnant women or nursing mothers
- •Subject has known respiratory condition
- •Subject has known cardiovascular disease
- •Subjects with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, haemophilia, current use of blood thinner: prescription or daily use of aspirin.
- •Subject on psychotropic drugs
- •Subject with Diabetes
- •Subject with artificial nails or nail polish
- •Subject with Raynaud’s disease
- •Critically ill individuals
- •Subjects with Haemoglobin <9 g/dL- Self reported
- •Subjects with carboxyhemoglobin levels larger than 3%
- •The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
- •Self-reported health conditions as identified in the Health Assessment Form (self-reported), diabetes, thyroid disease, kidney disease / chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent head injury, cancer / chemotherapy.
- •Subject participating in any other clinical trial or have had participated in any clinical trial within last 3 months or is on a follow up for any clinical trial.
结局指标
主要结局
The values obtained from the test device will be compared by the test values obtained by the co-oximeter and statistical analysis will be done as per the EVS-EN ISO 80601-2-61:2011.
时间窗: same day
次要结局
- Ease of use of test device will be determined as per the list of questionnaires.(same day)
研究者
研究点 (1)
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