Wearable Technology in Endoscopy

Overview

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

Full Title of Study: “A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Recorded tachycardia events
    • Time Frame: 1 day
    • Number of tachycardia events recorded as defined as heart rate > 100 bpm
  • Recorded bradycardia events
    • Time Frame: 1 day
    • Number of bradycardia events recorded as defined as heart rate < 60 bpm
  • Recorded desaturation events
    • Time Frame: 1 day
    • Number of desaturation events recorded as defined as peripheral O2 saturation <88%
  • Recorded arrhythmia events
    • Time Frame: 1 day
    • Number of arrhythmia events recorded
  • Recorded tachypnea
    • Time Frame: 1 day
    • Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vinay Chandrasekhara, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Vinay Chandrasekhara, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Blake Schleusner, 5074225839, schleusner.blake@mayo.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.