Skip to main content
OpenTrials
Completed

NCT Number: NCT05044104

Wearable Technology in Endoscopy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Consumer-facing wearable smart watch

Device

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

Primary outcomes

  1. Recorded Tachycardia Events

    Time frame: Anesthesia Duration, approximately 30 to 45 minutes

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

  2. Recorded Bradycardia Events

    Time frame: Anesthesia Duration, approximately 30 to 45 minutes

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

  3. Recorded Desaturation Events

    Time frame: Anesthesia Duration, approximately 30 to 45 minutes

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

  4. Recorded Arrhythmia Events

    Time frame: Anesthesia Duration, approximately 30 to 45 minutes

    Number of arrhythmia events recorded

  5. 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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2021
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.