Clinical trial NCT03574272: Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
Official title: Demonstration and Multi-center Verification of the Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Monitoring
Keywords: mobile IoT technology
Patient Transfer Monitoring System
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2018-06-29
Enrollment: 143
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who don't agree with the study procedure or are uncooperative
* Repeated monitoring of the same patient who already registered in the tiral

Primary outcomes:
measure: frequency of risk factors which are detected during transfer
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: severity of risk factors which are detected during transfer
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: reason of decreased oxygen saturation
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: duration of decreased oxygen saturation
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: change from baseline in Oxygen saturation
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: the time from detecting risk factor to medical response
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: Death
timeFrame: from admission to discharge, up to 8 months
measure: admission to intensive care units
timeFrame: from admission to discharge, up to 8 months
measure: Adverse events related to the study
timeFrame: from the beginning to immediately after the end of the patient transfer
measure: medical staffs who managed the alarmed event during transfer
timeFrame: from the beginning to immediately after the end of the patient transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National Univeristy Hospital
state: Gangwon-Do
city: Daejeon
country: Korea, Republic of
facility: DAVINCI hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Asan Medical Center
name: Chang-Min Choi, MD, Ph. D
role: PRINCIPAL_INVESTIGATOR
References: