Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology

Demonstration and Multi-center Verification of the Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology

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.

Study Overview

• Status: Completed
• Conditions: Patient Monitoring
• Intervention / Treatment: Other: Patient Transfer Monitoring System

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35262
    • DAVINCI hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyunghee University Medical Center
  • Wonju, Korea, Republic of, 26426
    • Wonju Severance Christian Hospital
  • Gangwon-Do
    • Chuncheon, Gangwon-Do, Korea, Republic of, 24289
      • Kangwon National Univeristy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Transfer Monitoring System	Other: Patient Transfer Monitoring System; The subjects will be provided with portable oximeter and smart-phone which application for monitoring is installed, and the transmitted data will be monitored in real time via monitoring equipment in the (Patient-hospitalized) ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of risk factors which are detected during transfer		from the beginning to immediately after the end of the patient transfer
severity of risk factors which are detected during 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).	from the beginning to immediately after the end of the patient transfer
reason of decreased oxygen saturation		from the beginning to immediately after the end of the patient transfer
duration of decreased oxygen saturation		from the beginning to immediately after the end of the patient transfer
change from baseline in Oxygen saturation		from the beginning to immediately after the end of the patient transfer
the time from detecting risk factor to medical response		from the beginning to immediately after the end of the patient transfer
Death		from admission to discharge, up to 8 months
admission to intensive care units		from admission to discharge, up to 8 months
Adverse events related to the study		from the beginning to immediately after the end of the patient transfer
medical staffs who managed the alarmed event during transfer		from the beginning to immediately after the end of the patient transfer

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Korea Health Industry Development Institute
• Investigators: Principal Investigator: Chang-Min Choi, MD, Ph. D, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): November 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: mobile IoT technology; Patient Transfer Monitoring System
• Other Study ID Numbers: C2018-00554

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No