Wearable Technology in Endoscopy

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05044104
Collaborator
(none)
500
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
55.7
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Device: Consumer-facing wearable smart watch
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

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/Treatment
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:
  • Apple Watch Series 6
  • FitBit Versa
  • Outcome Measures

    Primary Outcome Measures

    1. Recorded tachycardia events [1 day]

      Number of tachycardia events recorded as defined as heart rate > 100 bpm

    2. Recorded bradycardia events [1 day]

      Number of bradycardia events recorded as defined as heart rate < 60 bpm

    3. Recorded desaturation events [1 day]

      Number of desaturation events recorded as defined as peripheral O2 saturation <88%

    4. Recorded arrhythmia events [1 day]

      Number of arrhythmia events recorded

    5. Recorded tachypnea [1 day]

      Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Mayo Clinic in RochesterRochesterMinnesotaUnited States55905

    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.
    Responsible Party:
    Vinay Chandrasekhara, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05044104
    Other Study ID Numbers:
    • 21-007738
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by Vinay Chandrasekhara, Principal Investigator, Mayo Clinic

    Study Results

    No Results Posted as of Dec 2, 2021