eVent in the Human Patient Simulator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01240317
First received: November 10, 2010
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. To do this the investigators plan to use computer based simulations and test it when used by anesthesiologists in a full size human simulator. If these tests are successful the investigators will then be ready to evaluate eVENT on real patients.


Condition
To Evaluate the Efficacy of the Expert System in Enhancing the Anesthesiologist's Ability to Detect Critical Events in a Simulated OR Environment.

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)

Further study details as provided by University of British Columbia:

Enrollment: 36
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The development of new sensors or the intelligent synthesis of existing signals (smart sensors) cannot reliably prevent adverse events unless the investigators assimilate the data produced from these devices and provide it to the clinician in a format that is easy to comprehend. The expert system that the investigators are developing will provide intelligent synthesis of data. The clinician focus can then be directed toward the patient rather than continual observation of the monitors.

Clinicians need an expert system to augment vigilance and situation awareness, and to aid in decision making to prevent patient harm.

The development of an expert system to assist the everyday anesthesiologist in the operating room is a significant challenge that is in urgent need of being addressed. Assistance is required in interpreting the overwhelming stream of physiological data, intelligently extracting key features from these data, and bringing them to the attention of the clinician.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

anesthesiologists, anesthesia residents and fellows

Criteria

Inclusion Criteria:

  • Staff anesthesiologist, fellows and 3rd - 5th year residents will be able to participate in this study.
  • Subjects willing to provide informed consent.

Exclusion Criteria:

  • Inability/failure to provide informed consent.
  • Presence of any of the following conditions oPrevious participation in similar experiment oTaken sedative medication within last 24 hours
  • Inability/failure to obtain 75% or above in the post-training quiz on the correct use of the eVent.
  • Evaluation will be immediately discontinued at request of subject at any point during the study.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240317

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Mark Ansermino University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01240317     History of Changes
Other Study ID Numbers: H10-02621
Study First Received: November 10, 2010
Last Updated: November 24, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
expert system
decision support system
human patient simulator
anesthesia

ClinicalTrials.gov processed this record on August 26, 2014