SYSTEM AND METHOD FOR REAL TIME VITAL SIGN MONITORING USING IOT
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
Efforts will be made to different variety of subjects having following characteristics and diseases patterns; however, it is not compulsory to cover all following characteristics and diseases patterns.
· Healthy subject
· Patients with abnormal heart rate, blood pressures, SPO2, body temperature
· Patients with hard skin at finger tip
· Patients with soft skin at finger tip
· Patients with hard skin at finger tip
· Patients with obesity having swollen or fatty finger tip
Patients with thin finger tip
150 subjects are planned to be randomized into 6 sequences of 3 groups equally.
-
TRP
-
TPR
-
RTP
-
RPT
-
PTR
-
PRT
| Test Product Group |
(T)
Reference Products Group
(R)
Reference Procedure Group
(P)
|Following to be measured using Test Product
ü Heart rate
ü Systolic blood pressure
ü Diastolic blood pressure
ü SPO2
ü Body temperature
Following to be measured using Reference Products
ü Heart rate
ü Systolic blood pressure
ü Diastolic blood pressure
ü SPO2
ü Body temperature
Following to be measured using Reference Procedure – Sphygmomanometry using Mercury Sphygmomanometer
ü Heart rate
ü Systolic blood pressure
ü Diastolic blood pressure
· Subject will undergo screening based on the available medical records and will be enrolled in the study if the subject meets required criteria.
There is no likely to have any adverse event, but if happen, all adverse event will be captured and its association with use of ECG machine will be evaluated as per World Health Organization-Uppsala Monitoring Centre (WHO-UMC) definition of definite, probable, possible or unlikely.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 随机化方法
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- Any healthy subject or patient who voluntarily ready to undergo heart rate, systolic blood pressure, diastolic blood pressure, SPO2, body temperature 2.
- Any volunteer who gives informed consent to participate in this study.
排除标准
- Critically ill and clinically unstable patient who may not be comfortable to undergo the study process 2.
- Patient having any psychological illness which may compromise the patient’s compliance / co-operation for the study process.
结局指标
主要结局
Heart rate
时间窗: at baseline
Systolic blood pressure
时间窗: at baseline
SPO2
时间窗: at baseline
Body temperature
时间窗: at baseline
Diastolic blood pressure
时间窗: at baseline
次要结局
- Safety(at baseline)
- User Experience(at baseline)
研究者
研究点 (1)
标识符
- CTRI 编号
- CTRI/2025/06/089075
日期
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- 是
Will individual participant data (IPD) be shared publicly (including data dictionaries)? Response - YES What data in particular will be shared? Response - All of the individual participant data collected during the trial, after de-identification. What additional supporting information will be shared? Response - Clinical Study Report Who will be able to view these files? Response - Researchers who provide a methodologically sound proposal. For what types of analyses will this data be available? Response - Any purpose. By what mechanism will data be made available? Response (Others) - For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970 ? Response (Others) - Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL