- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612091
The Monitoring Messenger: Mobile Patient Monitoring for the Pediatric Intensive Care Unit
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monitoring Messenger
|
Monitoring Messenger prototype device
|
Active Comparator: Control
Traditional tools (monitors, paper records)
|
Paper based records, screenshots of monitors and therapy devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Requirements for design of the mobile device
Time Frame: Up to 2 hours
|
Information requirements for tasks, task frequencies, perceived challenges and potential suggestions to improve their current work environment using a mobile monitoring and messaging device
|
Up to 2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Ansermino, MBBCh, FRCPC, The University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H12-01270
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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