- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240317
eVent in the Human Patient Simulator
eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mark Ansermino, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H10-02621
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