Wearable Technology in Endoscopy
Study Details
Study Description
Brief Summary
Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This is a prospective, non-blinded, exploratory study to assess the accuracy and safety of wearable devices in the endoscopy suite with patients undergoing procedures using anesthesia assisted sedation using smart watches. We will also simultaneously perform an assessment of patient and provider preferences using narrative-driven, qualitative evaluation.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Wearable technology in endoscopic gastrointestinal procedures with sedation Subjects undergoing a endoscopic gastrointestinal procedure with sedation as part of standard of care will wear a consumer-facing wearable smart watch for the duration of the procedure. |
Device: Consumer-facing wearable smart watch
Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Recorded tachycardia events [1 day]
Number of tachycardia events recorded as defined as heart rate > 100 bpm
- Recorded bradycardia events [1 day]
Number of bradycardia events recorded as defined as heart rate < 60 bpm
- Recorded desaturation events [1 day]
Number of desaturation events recorded as defined as peripheral O2 saturation <88%
- Recorded arrhythmia events [1 day]
Number of arrhythmia events recorded
- Recorded tachypnea [1 day]
Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults over 18 years of age.
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Undergoing anesthesia-assisted endoscopic procedures.
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Able to give appropriate consent to the study or have an appropriate representative to do so.
Exclusion Criteria:
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Pregnancy.
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Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
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Allergy to aluminum, nickel or acrylate.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Vinay Chandrasekhara, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-007738