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Completed

NCT Number: NCT03574272

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.

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Key information

Conditions

Patient Monitoring

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangwon National Univeristy Hospital, Chuncheon, Gangwon-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Transfer Monitoring System

Other

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.

Primary outcomes

  1. frequency of risk factors which are detected during transfer

    Time frame: from the beginning to immediately after the end of the patient transfer

  2. severity of risk factors which are detected during transfer

    Time frame: from the beginning to immediately after the end of the patient 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).

  3. reason of decreased oxygen saturation

    Time frame: from the beginning to immediately after the end of the patient transfer

  4. duration of decreased oxygen saturation

    Time frame: from the beginning to immediately after the end of the patient transfer

  5. change from baseline in Oxygen saturation

    Time frame: from the beginning to immediately after the end of the patient transfer

  6. the time from detecting risk factor to medical response

    Time frame: from the beginning to immediately after the end of the patient transfer

  7. Death

    Time frame: from admission to discharge, up to 8 months

  8. admission to intensive care units

    Time frame: from admission to discharge, up to 8 months

  9. Adverse events related to the study

    Time frame: from the beginning to immediately after the end of the patient transfer

  10. medical staffs who managed the alarmed event during transfer

    Time frame: from the beginning to immediately after the end of the patient transfer

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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