Clinical trial NCT01240317: eVent in the Human Patient Simulator
Official title: eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Efficacy of the Expert System's Ability to Help Detect Critical Events
Keywords: expert system
decision support system
human patient simulator
anesthesia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesiologists, anesthesia residents and fellows

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mark Ansermino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorges M, Winton P, Koval V, Lim J, Stinson J, Choi PT, Schwarz SK, Dumont GA, Ansermino JM. An evaluation of an expert system for detecting critical events during anesthesia in a human patient simulator: a prospective randomized controlled study. Anesth Analg. 2013 Aug;117(2):380-91. doi: 10.1213/ANE.0b013e3182975b63. Epub 2013 Jun 18.