Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology

Patient Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574272
• Other study ID #: C2018-00554
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: December 28, 2018

Study information

• Verified date: March 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 28, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Monitoring

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kangwon National Univeristy Hospital	Chuncheon	Gangwon-Do
Korea, Republic of	DAVINCI hospital	Daejeon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	KyungHee University Medical Center	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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