NCT03574272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

May 27, 2018

Last Update Submit

March 6, 2019

Conditions

Patient Monitoring

Keywords

mobile IoT technologyPatient Transfer Monitoring System

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (1)

Patient Transfer Monitoring System

EXPERIMENTAL
Other: Patient Transfer Monitoring System

Interventions

Patient Transfer Monitoring SystemOTHER

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.

Patient Transfer Monitoring System

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Kangwon National Univeristy Hospital

Chuncheon, Gangwon-do, 24289, South Korea

Location

DAVINCI hospital

Daejeon, 35262, South Korea

Location

KyungHee University Medical Center

Seoul, 02447, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

Study Officials

  • Chang-Min Choi, MD, Ph. D

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 27, 2018

First Posted

June 29, 2018

Study Start

May 16, 2018

Primary Completion

November 28, 2018

Study Completion

December 28, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

KR(5)