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VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02970903
Recruitment Status : Withdrawn (We were unable to secure funding for the triaging experiment. The participatory design process ran its course as intended.)
First Posted : November 22, 2016
Last Update Posted : June 4, 2019
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Matthias Görges, PhD, University of British Columbia

Brief Summary:

The VitalPAD 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, followed by an evaluation of the proposed device in a simulated ICU setting.

Condition or disease Intervention/treatment Phase
Medical Device User-Computer Interface Critical Care Physiologic Monitoring Device: VitalPAD Device: Traditional tools Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU; Project Phases 1 (System Development) and 2 (Prototype Evaluation)
Estimated Study Start Date : October 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: VitalPAD
Using VitalPAD prototype device
Device: VitalPAD
VitalPAD prototype device

Active Comparator: Control
Using traditional tools (monitors, paper records)
Device: Traditional tools
Paper based records, screenshots of monitors and therapy devices

Primary Outcome Measures :
  1. Efficiency of priority assignment in triaging task [ Time Frame: Up to 1 hour ]
    Efficiency will be measured by the time it takes clinicians to prioritize 5 patients with/without the aid of the VitalPAD

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Usability questionnaire: NASA TLX [ Time Frame: Up to 1 hour ]
    NASA Task Load Index

  2. Usability questionnaire: PSSUQ [ Time Frame: Up to 1 hour ]
    Post-Study System Usability Questionnaire

  3. Usability feedback [ Time Frame: Up to 1 hour ]
    Free-text suggestions to improve prototype device

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Staff pediatric critical care physicians, pediatric critical care fellow physicians or attending physicians, registered pediatric nurses, and respiratory therapists working in the pediatric ICU at BC Children's Hospital

Exclusion Criteria:

  • Nursing students and resident physicians are not eligible.
  • For Phase II - Simulation Experiment only: Failure to complete the post-training quiz after two attempts.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02970903

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Canada, British Columbia
Pediatric Anesthesia Research Team, University of British Columbia
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Matthias Görges, PhD University of British Columbia
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Responsible Party: Matthias Görges, PhD, Principle Investigator, University of British Columbia Identifier: NCT02970903    
Other Study ID Numbers: H16-02361
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No