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

NCT ID: NCT01612091

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Medical Device User-Computer Interface Critical Care Physiologic Monitoring

Keywords

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Expert System Intensive Care Telemedicine Equipment Design

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Monitoring Messenger

Group Type EXPERIMENTAL

Monitoring Messenger

Intervention Type DEVICE

Monitoring Messenger prototype device

Control

Traditional tools (monitors, paper records)

Group Type ACTIVE_COMPARATOR

Traditional tools

Intervention Type DEVICE

Paper based records, screenshots of monitors and therapy devices

Interventions

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Monitoring Messenger

Monitoring Messenger prototype device

Intervention Type DEVICE

Traditional tools

Paper based records, screenshots of monitors and therapy devices

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Mark Ansermino

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Ansermino, MBBCh, FRCPC

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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http://www.part.cfri.ca/

Pediatric Anesthesia Research Team website

http://ecem.ece.ubc.ca/

Electrical \& Computer Engineering in Medicine (ECEM) website

Other Identifiers

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H12-01270

Identifier Type: -

Identifier Source: org_study_id