Smart EyewearNCT05184660
Smart Eyewear to Automatically Detect Drug Delivery Events
An observational study of Smart Eyewear, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smart Eyewear
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center.
Who may be able to join
- Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center
Who cannot join
- Medical students and anesthesiology residents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Kelly Michaelsen, MD, PhD, 716-908-5411, kellyem@uw.edu
Sharon Nguyen, BS, 2066188673, sharon17@uw.edu
About this study
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
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.
Read the 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.
- Conditions
- Smart Eyewear
- Keywords
- automatic detection, smart eyewear, drug delivery, drug administration, patient safety, anesthetic drug, anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating room footage
Operating room footage of drug preparation and drug delivery events recorded by anesthesia provider using a point-of-view device.
Measured: 8-10 hours
Secondary outcomes (1)
Computer vision toolkit
A computer vision toolkit which can identify syringes and medications in the hand of a provider in near real time.
Measured: 8-10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start4 Jan 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smart EyewearStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Michaelsen, University of Washington
- Investigators
- Kelly Michaelsen, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184660
- Sponsor's protocol ID
- STUDY00010313
- Status last verified
- May 2024
- First submitted
- 2 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05184660
- Acronym / sponsor ID
- STUDY00010313
- Conditions
- Smart Eyewear
- Keywords
- automatic detection, smart eyewear, drug delivery, drug administration, patient safety, anesthetic drug, anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center.
Key inclusion criteria (1 listed)
- Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center
Key exclusion criteria (1 listed)
- Medical students and anesthesiology residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Operating room footage
Time frame: 8-10 hours
Operating room footage of drug preparation and drug delivery events recorded by anesthesia provider using a point-of-view device.
1 secondary outcome
Computer vision toolkit
Time frame: 8-10 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Michaelsen, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smart Eyewear, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Michaelsen, MD, PhD (7169085411, kellyem@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operating room footage (time frame: 8-10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.