CClinicalTrials.gg
WithdrawnNCT01612091Updated Oct 26, 2017

The Monitoring Messenger: Mobile Patient Monitoring for the Pediatric Intensive Care Unit

An interventional study of Monitoring Messenger and Traditional tools in Medical Device, User-Computer Interface and Critical Care, sponsored by University of British Columbia. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by University of British Columbia · Not applicable, Interventional, and Basic science

Why this study was withdrawn
Replaced with updated protocol as H16-02361
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Medical Device
  • User-Computer Interface
  • Critical Care
  • Physiologic Monitoring

Keywords

  • Expert System
  • Intensive Care
  • Telemedicine
  • Equipment Design
03

In context

Lead sponsor

University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Monitoring Messenger

    Device: Monitoring Messenger

  • Active comparator
    Control

    Traditional tools (monitors, paper records)

    Device: Traditional tools

Interventions

  • DeviceMonitoring Messenger

    Monitoring Messenger prototype device

  • DeviceTraditional tools

    Paper based records, screenshots of monitors and therapy devices

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Up to 2 hours

07

Study locations

1 site
  • BC Children's Hospital
    Vancouver, British Columbia V6H 3V4, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01612091
Lead sponsor
University of British Columbia
Responsible party
Mark Ansermino (Principle Investigator, University of British Columbia) — Principal investigator
First posted
Jun 5, 2012
Start date
Nov 2013
Primary completion
Jan 2017 (estimated)
Completion
Jan 2017 (estimated)
Last update
Oct 26, 2017

Study contacts

Mark Ansermino, MBBCh, FRCPC
principal investigator · The University of British Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion