Medical DeviceNCT01612091
The Monitoring Messenger: Mobile Patient Monitoring for the Pediatric Intensive Care Unit
A study testing Monitoring Messenger and Traditional tools in people with Medical Device and User-Computer Interface, run by University of British Columbia at 1 site in Canada.
Trial summary
The Mobile Messenger is a unified, portable and intelligent device that integrates information from multiple patient monitors, mechanical ventilators, infusion pumps and clinical information systems on a mobile platform. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Device, User-Computer Interface, Critical Care
- What is being tested?
- Monitoring Messenger and Traditional tools
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Jan 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Staff pediatric critical care physicians, pediatric critical care fellow physicians, registered pediatric nurses and respiratory therapists will be eligible to participate in this study
- Subjects willing to provide informed consent
Who cannot join
- Inability/failure to provide informed consent.
- Nursing students and resident physicians are not eligible
- For Part II - Simulation Experiment only: Failure to complete the post-training quiz more than twice.
- Evaluation will be immediately discontinued at request of subject at any point during the study.
Trial locations and contacts
1 site in 1 country.
About this study
The Mobile Messenger is a unified, portable and intelligent device that integrates information from multiple patient monitors, mechanical ventilators, infusion pumps and clinical information systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to continuously monitor and coordinate care of critically ill patients. This study will use a participatory design process to guide the design of an integrated mobile device. Next, we will evaluate the proposed device in a simulated ICU setting.
Read the detailed description
There are a limited number of nurses, respiratory therapists and physicians in an ICU at a given time. To make decisions and plan therapies, these clinicians need to observe, assimilate and interpret a vast array of information originating from various devices located on the bedsides of multiple patients. Several shortcomings in existing technology limit their abilities: a) the fixed location of monitoring devices at the bedside; b) information overload from a multitude of devices, each with its own display; c) the lack of integration and interaction between these devices; d) the use of visually cumbersome displays, which were historically created for monitoring during anesthesia but never optimized for users in the ICU; and e) lack of context specific information (such as historical trends) to support patient data interpretation and clinical decision making.
This project proposes to address these challenges in ICU monitoring by developing a unified, portable, and intelligent device: the Monitoring Messenger. By integrating information from multiple monitoring devices, mechanical ventilators, infusion pumps and clinical information systems on a mobile device (tablet PC or smart phone); the Monitoring Messenger will allow nurses, respiratory therapists and physicians on or off-site, to continuously monitor critically ill patients, thereby increasing patient safety.
The proposed experiment will have two parts: Part I - Participatory design and Part II - Simulation Experiment.
In Part I - Participatory Design. Participatory design an inter-professional team of nurses, physicians, designers, engineers, and human factors experts will follow a user-centered design process to obtain the system requirements, and obtain feedback during the rapid prototyping phase of prototype development. While we expect the resulting prototype to be easy to use, support decision making, improve awareness of the patient's condition by health care providers and reduce mental workload, this methodology is not hypothesis driven.
Part II - Simulation Experiment. In simulated ICU scenarios, the critical care physicians, nurses, and respiratory therapists will prioritize the care of critically ill patients. We expect them to do so more accurately with the use of Monitoring Messenger than with their regular tool (monitors, paper records etc). A potential outcome would be a decrease in mental workload as well as an increase in situational awareness.
- Being tested
- Monitoring Messenger, Traditional tools
- Keywords
- Expert System, Intensive Care, Telemedicine, Equipment Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring MessengerDevice
Monitoring Messenger prototype device
Traditional toolsDevice
Paper based records, screenshots of monitors and therapy devices
| Study group | Role | What they receive |
|---|---|---|
| Monitoring Messenger | Experimental | Not described Receives: Device: Monitoring Messenger |
| Control | Active comparator | Traditional tools (monitors, paper records) Receives: Device: Traditional tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of priority assignment in triaging task
Accuracy will be measured by matching of the participants triage priority ranking with the previously defined expert ranking.
Measured: Up to 1 hour
Secondary outcomes (1)
Requirements for design of the mobile device
Information requirements for tasks, task frequencies, perceived challenges and potential suggestions to improve their current work environment using a mobile monitoring and messaging device
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startNov 2013
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: Replaced with updated protocol as H16-02361
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical DeviceStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ansermino, University of British Columbia
- Investigators
- Mark Ansermino, MBBCh, FRCPC, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612091
- Sponsor's protocol ID
- H12-01270
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2012
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Monitoring Messenger: Mobile Patient Monitoring for the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01612091
- Acronym / sponsor ID
- H12-01270
- Keywords
- Expert System, Intensive Care, Telemedicine, Equipment Design
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with updated protocol as H16-02361
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Jun 2012 (estimated)
- 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 Mobile Messenger is a unified, portable and intelligent device that integrates information from multiple patient monitors, mechanical ventilators, infusion pumps and clinical information systems on a mobile platform. It will allow nurses, respiratory therapists and physicians to continuously monitor and coordinate care of critically ill patients. This study will use a participatory design process to guide the design of an integrated mobile device. Next, we will evaluate the proposed device in a simulated ICU setting.
Detailed description
There are a limited number of nurses, respiratory therapists and physicians in an ICU at a given time. To make decisions and plan therapies, these clinicians need to observe, assimilate and interpret a vast array of information originating from various devices located on the bedsides of multiple patients. Several shortcomings in existing technology limit their abilities: a) the fixed location of monitoring devices at the bedside; b) information overload from a multitude of devices, each with its own display; c) the lack of integration and interaction between these devices; d) the use of visually cumbersome displays, which were historically created for monitoring during anesthesia but never optimized for users in the ICU; and e) lack of context specific information (such as historical trends) to support patient data interpretation and clinical decision making.
This project proposes to address these challenges in ICU monitoring by developing a unified, portable, and intelligent device: the Monitoring Messenger. By integrating information from multiple monitoring devices, mechanical ventilators, infusion pumps and clinical information systems on a mobile device (tablet PC or smart phone); the Monitoring Messenger will allow nurses, respiratory therapists and physicians on or off-site, to continuously monitor critically ill patients, thereby increasing patient safety.
The proposed experiment will have two parts: Part I - Participatory design and Part II - Simulation Experiment.
In Part I - Participatory Design. Participatory design an inter-professional team of nurses, physicians, designers, engineers, and human factors experts will follow a user-centered design process to obtain the system requirements, and obtain feedback during the rapid prototyping phase of prototype development. While we expect the resulting prototype to be easy to use, support decision making, improve awareness of the patient's condition by health care providers and reduce mental workload, this methodology is not hypothesis driven.
Part II - Simulation Experiment. In simulated ICU scenarios, the critical care physicians, nurses, and respiratory therapists will prioritize the care of critically ill patients. We expect them to do so more accurately with the use of Monitoring Messenger than with their regular tool (monitors, paper records etc). A potential outcome would be a decrease in mental workload as well as an increase in situational awareness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring Messenger | Experimental | Device: Monitoring Messenger |
| Control | Active comparator | Device: Traditional toolsTraditional tools (monitors, paper records) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Staff pediatric critical care physicians, pediatric critical care fellow physicians, registered pediatric nurses and respiratory therapists will be eligible to participate in this study
- Subjects willing to provide informed consent
Key exclusion criteria (4 listed)
- Inability/failure to provide informed consent.
- Nursing students and resident physicians are not eligible
- For Part II - Simulation Experiment only: Failure to complete the post-training quiz more than twice.
- Evaluation will be immediately discontinued at request of subject at any point during the study.
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 |
|---|---|---|
| Monitoring MessengerMonitoring Messenger prototype device | Device | Monitoring Messenger |
| Traditional toolsPaper based records, screenshots of monitors and therapy devices | Device | Control |
Primary outcome
Accuracy of priority assignment in triaging task
Time frame: Up to 1 hour
Accuracy will be measured by matching of the participants triage priority ranking with the previously defined expert ranking.
1 secondary outcome
Requirements for design of the mobile device
Time frame: Up to 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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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.
Mark Ansermino, MBBCh, FRCPC principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring Messenger and Traditional tools in people with Medical Device and User-Computer Interface, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 26 Oct 2017. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of priority assignment in triaging task (time frame: Up to 1 hour). 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 26 Oct 2017.