Demonstration and Multi-center Verification of the Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 10
- 主要终点
- change from baseline in Oxygen saturation
研究概览
简要总结
This trial is multi-center prospective study to develop Patient Transfer Monitoring system using mobile lot network and the Risk Factor Detection System and apply to real In-Hospital Patients and verify the efficacy.
详细描述
Hospitalized patients who need transfer for a diagnostic examination or rehabilitation therapy during hospitalization, and have a risk of hypoxemia during transfer will be enrolled in this trial. The subjects will be provided with a portable oximeter and a smart-phone which application for monitoring is installed, and oxygen saturation and pulse rate will be checked in real time during transfer. The collected data will be transferred to cloud system via Iot network, and the transmitted data will be monitored in real time via monitoring equipment in the (Patient-hospitalized) ward. If there is a risk, the alarm system is activated so that the medical team is able to check risk factor and manage it immediately.
All the risk factors and severity will be collected during transfer, also these are checked whether the monitoring system and the data transmission system work properly or not, the time from detecting risk factor to medical response, the composition of medical staffs who responding to alarmed risk factors and improvement of the subjects.
Pilot study will be conducted with 20 subjects in Asan medical center. In pilot study, monitoring machines (HR, SpO2 monitor) commonly used in wards or hospitals will be used to verify the stability of oximeter used in this study and the developed risk detection system.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A hospitalized patients in pulmonology department or rehabilitation hospital who have a risk of decreasing oxygen saturation
- •A patients who require transfer in the hospital for a diagnostic examination or rehabilitation therapy during hospitalization
- •Patients who need oxygen saturation monitoring according to the investigator's judgment
- •Patients who voluntarily agree to study participation and provide written informed consent form
排除标准
- •Patients who don't agree with the study procedure or are uncooperative
- •Repeated monitoring of the same patient who already registered in the tiral
研究组 & 干预措施
Patient Transfer Monitoring System
干预措施: Patient Transfer Monitoring System (Other)
结局指标
主要结局
change from baseline in Oxygen saturation
时间窗: from the beginning to immediately after the end of the patient transfer
frequency of risk factors which are detected during transfer
时间窗: from the beginning to immediately after the end of the patient transfer
duration of decreased oxygen saturation
时间窗: from the beginning to immediately after the end of the patient transfer
severity of risk factors which are detected during transfer
时间窗: from the beginning to immediately after the end of the patient transfer
The severity is assessed as mild(risk factor was resolved without medical staff), moderate(resolved by medical staffs, but returned to the ward), and severe(not resolved by medical staffs, needs other method such as CPCR call, invasive intervention).
reason of decreased oxygen saturation
时间窗: from the beginning to immediately after the end of the patient transfer
the time from detecting risk factor to medical response
时间窗: from the beginning to immediately after the end of the patient transfer
Death
时间窗: from admission to discharge, up to 8 months
medical staffs who managed the alarmed event during transfer
时间窗: from the beginning to immediately after the end of the patient transfer
admission to intensive care units
时间窗: from admission to discharge, up to 8 months
Adverse events related to the study
时间窗: from the beginning to immediately after the end of the patient transfer
次要结局
未报告次要终点
研究者
Chang-Min Choi
associate professor
Asan Medical Center