Wearable Technology in Endoscopy

Study Overview
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Brief Summary
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Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.

Detailed Description
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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.

Official Title
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A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy

Conditions
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Healthy

Intervention / Treatment
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* Device: Consumer-facing wearable smart watch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable technology in endoscopic gastrointestinal procedures with sedation<br>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<br>* Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.<br>* Other names: FitBit Versa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recorded Tachycardia Events | Number of tachycardia events recorded as defined as heart rate > 100 bpm | Anesthesia Duration, approximately 30 to 45 minutes | 
| Recorded Bradycardia Events | Number of bradycardia events recorded as defined as heart rate < 60 bpm | Anesthesia Duration, approximately 30 to 45 minutes | 
| Recorded Desaturation Events | Number of desaturation events recorded as defined as peripheral O2 saturation <88% | Anesthesia Duration, approximately 30 to 45 minutes | 
| Recorded Arrhythmia Events | Number of arrhythmia events recorded | Anesthesia Duration, approximately 30 to 45 minutes | 
| Recorded Tachypnea | Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute | Anesthesia Duration, approximately 30 to 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Endoscopic Procedure with sedation