A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- Recorded Bradycardia Events
Study Overview
Brief Summary
Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults over 18 years of age.
- •Undergoing anesthesia-assisted endoscopic procedures.
- •Able to give appropriate consent to the study or have an appropriate representative to do so.
Exclusion Criteria
- •Pregnancy.
- •Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
- •Allergy to aluminum, nickel or acrylate.
Arms & Interventions
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.
Intervention: Consumer-facing wearable smart watch (Device)
Outcomes
Primary Outcomes
Recorded Bradycardia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of bradycardia events recorded as defined as heart rate \< 60 bpm
Recorded Arrhythmia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of arrhythmia events recorded
Recorded Desaturation Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of desaturation events recorded as defined as peripheral O2 saturation \<88%
Recorded Tachycardia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachycardia events recorded as defined as heart rate \> 100 bpm
Recorded Tachypnea
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of tachypnea events recorded as defined as respiratory rate \>18 breaths per minute
Secondary Outcomes
No secondary outcomes reported
Investigators
Vinay Chandrasekhara
Principal Investigator
Mayo Clinic