Emergency MedicineIT5GRHSCINCT06485518
Integration of the 5G-based Remote Healthcare System in Critical Care
An observational study of Emergency Medicine and Telemedicine, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, Telemedicine, Augmented Reality
- What is being tested?
- The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Aug 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, patients with acute chest pain, stroke and trauma will be enrolled in the departments of emergency medicine in the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.
Who may be able to join
- 1) Age range (≥18 years old).
- 2) Patients with acute chest pain, stroke and trauma were diagnosed in the departments of emergency medicine of the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.
- 3) Voluntarily participate in the study and sign the informed consent; If the subject does not have the ability to understand or sign the informed consent, his/her guardian will represent him/her in the informed process and agree to participate in the study; If illiterate, his/her will need a witness to witness the knowledge process and his/her will decide to participate in the study.
Who cannot join
- 1) Incomplete clinical data.
- 2) Minors.
- 3) Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310012
About this study
Official title: Integration of the 5G-based Remote Healthcare System in Critical Care: A Comprehensive Report With Multiple Satellite Sites
The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific improvements in various use cases (e.g., emergency room, diagnosis, treatment, task guidance, and medical education) and to examine whether factors such as the expertise of central physicians, patient and physician locations, and the timing of calls influence clinical outcomes.
Read the detailed description
Background: Augmented Reality (AR) has undergone rapid development in recent years, gaining prominence in healthcare, especially when coupled with 5G internet technology. This study delves into the integration of 5G Augmented Reality in emergency medicine, with a focus on its impact on clinical outcomes.
Methods: This study will utilize the 5G-based Remote Healthcare System (5G RHS) to connect four satellite Emergency Room (ER) teams with central experts to assess its effectiveness in critical cases. Data will be collected from July 2022 to June 2023 to address key research questions, including the circumstances prompting the use of 5G RHS, the extent of clinical improvement achieved, and the influence of central physician expertise, patient and physician locations, and calling time on clinical outcomes.
- Conditions
- Emergency Medicine, Telemedicine, Augmented Reality
- Being tested
- The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.
- Keywords
- Teleconference, Mentoring, Augmented Reality, Emergency, Patient outcome
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.Behavioural
The 5G RHS group will receive audio-video conferencing and effective data management for decision-making via augmented reality platform. A total of 14 physicians from SRRSH will be participated in the study, offering remote consultations and instant guidance to the physician.
| Study group | Role | What they receive |
|---|---|---|
| 5G RHS group | For all patients receiving care through the 5G-based Remote Healthcare System (5G RHS) teleconsultation platform during the specified time period Receives: Behavioral: The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
critical conditions
For all patients receiving care through the 5G RHS platform during the specified time period, we gathered clinical data from electronic health records (EHRs). This data encompasses information related to critical conditions.
Measured: from July 2022 to June 2023
background situation
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to the emergency situation,
Measured: from July 2022 to June 2023
reasons for consultation
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to reasons for seeking remote consultation (including complex challenges, new medical scenarios, and educational interactions).
Measured: from July 2022 to June 2023
treatment outcomes
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to treatment outcomes.
Measured: from July 2022 to June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yucai Hong, Sir Run Run Shaw Hospital
- Investigators
- Yecheng Jin, M.D, Study director, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485518
- Sponsor's protocol ID
- ky20220304-31
- Other IDs
- 2023YFC3603100
- Acronym
- IT5GRHSCI
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 1. The data are not publicly available due to their containing information that could compromise the privacy of research participants. 2. Data cannot be shared openly but are available on request from authors for some reasonable conditions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of the 5G-based Remote Healthcare System in Critical Care: A Comprehensive Report With Multiple Satellite Sites
- ClinicalTrials.gov ID
- NCT06485518
- Acronym / sponsor ID
- IT5GRHSCI / ky20220304-31
- Conditions
- Emergency Medicine, Telemedicine, Augmented Reality
- Keywords
- Teleconference, Mentoring, Augmented Reality, Emergency, Patient outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 3 Jul 2024 (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.
The primary objective of this initial report is to address the following questions: Under what circumstances do clinical teams at satellite locations utilize the 5G RHS? Does the implementation of 5G RHS result in significant clinical enhancements? Furthermore, additional analyses will be conducted to assess specific improvements in various use cases (e.g., emergency room, diagnosis, treatment, task guidance, and medical education) and to examine whether factors such as the expertise of central physicians, patient and physician locations, and the timing of calls influence clinical outcomes.
Detailed description
Background: Augmented Reality (AR) has undergone rapid development in recent years, gaining prominence in healthcare, especially when coupled with 5G internet technology. This study delves into the integration of 5G Augmented Reality in emergency medicine, with a focus on its impact on clinical outcomes.
Methods: This study will utilize the 5G-based Remote Healthcare System (5G RHS) to connect four satellite Emergency Room (ER) teams with central experts to assess its effectiveness in critical cases. Data will be collected from July 2022 to June 2023 to address key research questions, including the circumstances prompting the use of 5G RHS, the extent of clinical improvement achieved, and the influence of central physician expertise, patient and physician locations, and calling time on clinical outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5G RHS group | – | Behavioral: The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.For all patients receiving care through the 5G-based Remote Healthcare System (5G RHS) teleconsultation platform during the specified time period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, patients with acute chest pain, stroke and trauma will be enrolled in the departments of emergency medicine in the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.
Key inclusion criteria (3 listed)
- 1) Age range (≥18 years old).
- 2) Patients with acute chest pain, stroke and trauma were diagnosed in the departments of emergency medicine of the relevant medical community, Branches of Run Run Shaw Hospital, Zhejiang University School of Medicine.
- 3) Voluntarily participate in the study and sign the informed consent; If the subject does not have the ability to understand or sign the informed consent, his/her guardian will represent him/her in the informed process and agree to participate in the study; If illiterate, his/her will need a witness to witness the knowledge process and his/her will decide to participate in the study.
Key exclusion criteria (3 listed)
- 1) Incomplete clinical data.
- 2) Minors.
- 3) Pregnant women.
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 |
|---|---|---|
| The 5G RHS group receiving audio-video conferencing and effective data management for decision-making via augmented reality platform RealHealthcare System.The 5G RHS group will receive audio-video conferencing and effective data management for decision-making via augmented reality platform. A total of 14 physicians from SRRSH will be participated in the study, offering remote consultations and instant guidance to the physician. | Behavioural | 5G RHS group |
Primary outcome
critical conditions
Time frame: from July 2022 to June 2023
For all patients receiving care through the 5G RHS platform during the specified time period, we gathered clinical data from electronic health records (EHRs). This data encompasses information related to critical conditions.
background situation
Time frame: from July 2022 to June 2023
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to the emergency situation,
reasons for consultation
Time frame: from July 2022 to June 2023
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to reasons for seeking remote consultation (including complex challenges, new medical scenarios, and educational interactions).
treatment outcomes
Time frame: from July 2022 to June 2023
For all patients receiving care through the 5G RHS platform during the specified time period, we will gather clinical data from electronic health records (EHRs). This data encompasses information related to treatment outcomes.
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 3 Jul 2024.
- Individual participant dataSharing planned: Undecided. 1. The data are not publicly available due to their containing information that could compromise the privacy of research participants. 2. Data cannot be shared openly but are available on request from authors for some reasonable conditions.
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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.
Yecheng Jin, M.D study director
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Medicine and Telemedicine, run by Sir Run Run Shaw Hospital at 1 site in China.
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 3 inclusion and 3 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 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
critical conditions (time frame: from July 2022 to June 2023). The study lists 4 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 3 Jul 2024.