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

NCT02970903 | Withdrawn

• 1 other identifier: H16-02361
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Efficiency of priority assignment in triaging task

  Efficiency will be measured by the time it takes clinicians to prioritize 5 patients with/without the aid of the VitalPAD

  Up to 1 hour

Secondary Outcomes (1)

• Accuracy of priority assignment in triaging task

  Up to 1 hour

Other Outcomes (3)

• Usability questionnaire: NASA TLX

  Up to 1 hour

• Usability questionnaire: PSSUQ

  Up to 1 hour

• Usability feedback

  Up to 1 hour

Study Arms (2)

VitalPAD

EXPERIMENTAL

Using VitalPAD prototype device

Device: VitalPAD

Control

ACTIVE COMPARATOR

Using traditional tools (monitors, paper records)

Device: Traditional tools

Interventions

VitalPAD DEVICE

VitalPAD prototype device

VitalPAD

Traditional tools DEVICE

Paper based records, screenshots of monitors and therapy devices

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Pediatric Anesthesia Research Team, University of British Columbia

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Study Officials

• Matthias Görges, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: November 22, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)