Patient MonitoringNCT03574272
Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
A study testing Patient Transfer Monitoring System in people with Patient Monitoring, run by Asan Medical Center at 5 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Patient Monitoring
- What is being tested?
- Patient Transfer Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 16 May 2018to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who don't agree with the study procedure or are uncooperative
- Repeated monitoring of the same patient who already registered in the tiral
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Kangwon National Univeristy Hospital
Chuncheon, Gangwon-do, 24289
DAVINCI hospital
Daejeon, 35262
KyungHee University Medical Center
Seoul, 02447
Asan Medical Center
Seoul, 05505
Wonju Severance Christian Hospital
Wŏnju, 26426
About this study
Official title: 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.
Read the 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.
- Conditions
- Patient Monitoring
- Being tested
- Patient Transfer Monitoring System
- Keywords
- mobile IoT technology, Patient Transfer Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Transfer Monitoring System | Experimental | Not described Receives: Other: Patient Transfer Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of risk factors which are detected during transfer
Measured: 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).
Measured: from the beginning to immediately after the end of the patient transfer
reason of decreased oxygen saturation
Measured: from the beginning to immediately after the end of the patient transfer
duration of decreased oxygen saturation
Measured: from the beginning to immediately after the end of the patient transfer
change from baseline in Oxygen saturation
Measured: from the beginning to immediately after the end of the patient transfer
the time from detecting risk factor to medical response
Measured: from the beginning to immediately after the end of the patient transfer
Death
Measured: from admission to discharge, up to 8 months
admission to intensive care units
Measured: from admission to discharge, up to 8 months
Adverse events related to the study
Measured: from the beginning to immediately after the end of the patient transfer
medical staffs who managed the alarmed event during transfer
Measured: from the beginning to immediately after the end of the patient transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start16 May 2018
- Primary completion28 Nov 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient MonitoringStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Chang-Min Choi, Asan Medical Center
- Investigators
- Chang-Min Choi, MD, Ph. D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574272
- Sponsor's protocol ID
- C2018-00554
- Status last verified
- Mar 2019
- First submitted
- 27 May 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration and Multi-center Verification of the Patient Transfer Monitoring System in Hospital Using Mobile IoT Technology
- ClinicalTrials.gov ID
- NCT03574272
- Acronym / sponsor ID
- C2018-00554
- Conditions
- Patient Monitoring
- Keywords
- mobile IoT technology, Patient Transfer Monitoring System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 16 May 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Transfer Monitoring System | Experimental | Other: Patient Transfer Monitoring System |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who don't agree with the study procedure or are uncooperative
- Repeated monitoring of the same patient who already registered in the tiral
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Transfer Monitoring SystemThe 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. | Other | Patient Transfer Monitoring System |
Primary outcome
frequency of risk factors which are detected during transfer
Time frame: from the beginning to immediately after the end of the patient transfer
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).
reason of decreased oxygen saturation
Time frame: from the beginning to immediately after the end of the patient transfer
duration of decreased oxygen saturation
Time frame: from the beginning to immediately after the end of the patient transfer
change from baseline in Oxygen saturation
Time frame: from the beginning to immediately after the end of the patient transfer
the time from detecting risk factor to medical response
Time frame: from the beginning to immediately after the end of the patient transfer
Death
Time frame: from admission to discharge, up to 8 months
admission to intensive care units
Time frame: from admission to discharge, up to 8 months
Adverse events related to the study
Time frame: from the beginning to immediately after the end of the patient transfer
medical staffs who managed the alarmed event during transfer
Time frame: from the beginning to immediately after the end of the patient transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Min Choi, MD, Ph. D principal investigator
Asan Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Transfer Monitoring System in people with Patient Monitoring, run by Asan Medical Center at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of risk factors which are detected during transfer (time frame: from the beginning to immediately after the end of the patient transfer). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.