Bravo1 Patient Monitor (PM) Platform:Core Body Temperature, Heart Rate and Respiration Rate Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- • Respiration Rate Data collected on the ML Explorer app.
研究概览
简要总结
The purpose of this protocol is to perform clinicalvalidation activities for the monitoring of core body temperature, heart rate (HR) and respiration rate (RR)for the BraveHeart Wireless, Inc. (BHW) Bravo1 Patient Monitor (PM) Platform. Additionally, to simultaneously conduct data collectionactivities for temperature and RR monitoring of the Analog Devices (ADI) Fenda and SpO2 watches in thespirit of a Joint Development Agreement executed between BHW and ADI. To collect, evaluate, compare and validate clinicallyobtained core body temperature results, as measured by a known FDA cleared digital thermometer(utilizing traditional and generally accepted clinical methods) against the non-invasive, chestworn Bravo1 PM Platform skin temperature results for all study subjects. To collect, evaluate, compare and validate clinical RRmonitoring results for the Bravo1 PM Platform against known FDA cleared reference devicesutilizing nasal/oral-worn capnography and/or finger-worn photoplethysmography (PPG) for all studysubjects.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 64.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢All subjects shall be at least 18 years or older. •In good general health without any evidence of medical issues and/or problems. •The subject must have the ability to understand and provide written informed consent. •The subject must be willing and able to comply with study procedures and duration. •Male or female of any race but a wide demographic across age, gender and race is preferred. •It is required, by ISO 80601-2-56, that 30%.
- •50% of subjects shall be recruited that demonstrate as febrile from the population of all subjects identified for the study. •A febrile subject is someone having: â–ª An elevated core temperature of 38.0 Dec C (100.4 Deg F) or higher as measure by the Reference Clinical Thermometer (RCT). â–ª An elevated sublingual temperature of 37.5 Deg C (99.5 Deg F) or higher as measured by the RCT, or â–ª An elevated axillary temperature of 37.2 Deg C (99.0 Deg F) or higher as measured by the RCT.
排除标准
- •â€¢The subject is a current smoker •The subject is pregnant, lactating or trying to get pregnant.
- •â€¢The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •â€¢Diagnosis of asthma, sleep apnea, or use of CPAP.
- •â€¢Diagnosed or self-reported respiratory diseases/impairment.
- •â€¢Diagnosed or self-reported cardiovascular diseases/impairment.
- •â€¢Subjects with inflammation at the measuring site.
- •â€¢Subjects that have taken antipyretics in the preceding 120 min.
- •â€¢Subjects meeting contraindications for device •Subjects showing inflammation or skin damage at the measuring site (i.e., if site selection has open wounds, erythema, redness, old scar/wounds) •Subjects with known skin allergies (e.g., silicone or hydrocolloid adhesives and/or hydrogel) •The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
- •â€¢The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
结局指标
主要结局
• Respiration Rate Data collected on the ML Explorer app.
时间窗: 1.5 Hours
• HR data collected on the ML Explorer App.
时间窗: 1.5 Hours
• Core body Temperature Data recorded from the reference clinical thermometer
时间窗: 1.5 Hours
(RCT) as noted against the Bravo1 PM Platform skin temperature results.
时间窗: 1.5 Hours
• Respiration Rate Data collected with the CapnosteamTM20p Portable Bedside
时间窗: 1.5 Hours
Monitor Capnograph.
时间窗: 1.5 Hours
• Multi-modality bio signals (PPG, temperature, motion) collected with ADI Fenda
时间窗: 1.5 Hours
and SpO2 watches.
时间窗: 1.5 Hours
次要结局
- • Respiration Rate Data collected on the ML Explorer app.(• HR data collected on the ML Explorer App.)