Clinical trial NCT05184660: Smart Eyewear to Automatically Detect Drug Delivery Events
Official title: The Use of a Wearable Data Input Device (Google Glass, Microsoft HoloLens or GoPro Like Camera Mounted to Eyewear) to Collect Drug Delivery Event Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smart Eyewear
Keywords: automatic detection
smart eyewear
drug delivery
drug administration
patient safety
anesthetic drug
anesthesia
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center.

Brief summary: This project is designed as a prospective observational study of medication preparation and delivery using a novel wearable data input device to automate detection of drug delivery events in the anesthesia workspace at University of Washington Medical Center.

Detailed description: Detailed Summary: The goal of this study is to devise a high-fidelity system that automatically collects data about anesthesia care, specifically drug preparation and delivery to the patient. We use a novel wearable data input device that collects computer processed images (video only, no audio) to determine details of the preparation and delivery of medications in the operating room. The wearable data input device is used by an anesthesia provider. The device collects computer processed images and in the anesthesia workspace, which will be used to develop machine learning algorithms that can automatically recognize drug administration events in order to automate medical record keeping in this environment.

Procedure: The principle investigator or a study coordinator will review the electronic operating room schedule to screen for potential data collection. The operating room team will be notified of the study the day prior to and day of data collection. The consented anesthesia provider will wear a point of view device to record drug preparation and drug delivery events in the operating room. Video recordings will be edited to remove Protected Health Information (PHI). Edited footage will then be annotated by volunteers on a computer vision learning tool website. The computer processed images will be then used to develop machine learning algorithms that can automatically recognize drug administration events.

Participants: The initial recruitment goal for the study is 10 nurse anesthetists recording 5 days each in the operating room. Nurse anesthetists are recruited as participants through word of mouth. If determined after data analysis that additional data needs to collected, additional anesthesia providers will be consented.

Eligibility criteria: Inclusion Criteria:

* Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center

Exclusion Criteria:

* Medical students and anesthesiology residents

Primary outcomes:
measure: Operating room footage
timeFrame: 8-10 hours
Secondary outcomes:
measure: Computer vision toolkit
timeFrame: 8-10 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Kelly Michaelsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: