A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Mayo Clinic
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- Recorded Arrhythmia Events
- Status
- Completed
- Last Updated
- 2 years ago
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.
Investigators
Vinay Chandrasekhara
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Bradycardia Events
Time Frame: Anesthesia Duration, approximately 30 to 45 minutes
Number of bradycardia events recorded as defined as heart rate \< 60 bpm
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