NCT03641937终止不适用
INVSENSOR00011 Clinical Performance Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sensitivity of INVSENSOR00011's Posture Change Detection
研究概览
简要总结
This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years old
- •Physical status of ASA I or II
- •Must be able to read and communicate in English
- •Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement
- •Passed health assessment screening
排除标准
- •Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
- •Inability to tolerate sitting still or minimal movement for at least 30 minutes
- •Nursing female volunteers
- •Excluded at the Principal Investigator's discretion
- •Refusal to take pregnancy test (for female subjects)
- •Positive pregnancy tests for female subjects of child bearing potential.
- •Refusal to shave hair off areas where sensors will be applied (male subjects)
研究组 & 干预措施
INVSENSOR00011 Test group
Experimental
The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.
干预措施: INVSENSOR00011 (Device)
结局指标
主要结局
Sensitivity of INVSENSOR00011's Posture Change Detection
时间窗: Approximately 30 minutes
Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
次要结局
- Respiratory Rate Detection(Approximately 20 minutes)
研究者
研究点 (1)
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