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

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ClinicalTrials.gov Identifier: NCT02970903
Recruitment Status : Enrolling by invitation
First Posted : November 22, 2016
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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)
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02970903


Locations
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)
Investigators
Principal Investigator: Matthias Görges, PhD University of British Columbia

Responsible Party: Matthias Görges, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02970903     History of Changes
Other Study ID Numbers: H16-02361
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No