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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03574272
Other study ID # C2018-00554
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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