- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05029674
Understanding Performance: Enhancing Recovery as Surgeons (ERAS)
Use of Biometric Data to Understand Surgeon Performance, Strain, and Recovery
Study Overview
Detailed Description
Participants will be asked to wear a biometric sensor for six months. The biometric sensor, namely, 'The Whoop strap' collects heart rate and heart rate variability data.
Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, exercise and mindfulness, and surgical performance as well as video and audio recordings during a simulated surgical task.
Surveys will be individually numbered and a master list of subject number and video, audio, and sensor ID will be kept in a separate location. This practice will enable us to better understand survey feedback by reviewing relevant videos, images, and sensor recordings. Images and data associated with a subject will be labeled with the subject number only.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Study participants will include trainee and attending surgeons
Exclusion Criteria:
- Exclusion criteria will be anyone who is not full-time clinically active as a surgical trainee or attending
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgeon Recovery
Time Frame: 6-12 months
|
A daily Recovery score from 0-100% (0-33% is poor recovery, 34-66% is medium recovery, 67-100% is good recovery) is calculated using the WHOOP algorithm which takes resting heart rate, heart rate variability, and sleep metrics into account.
|
6-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Strain
Time Frame: 6-12 months
|
Strain scores are calculated using the WHOOP algorithm which uses heart rate, activity, and duration of activity.
The Clinical Strain will refer to the Strain calculated by the WHOOP strap that occurs during clinical activities including overnight call and operative cases.
|
6-12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58625
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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