Wearable Technology in Endoscopy

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT05044104
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-09-04
• Study First Submitted QC: 2021-09-04
• Study First Posted: 2021-09-14
• Study Start: 2022-01-11
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Results First Submitted: 2023-06-16
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Results First Posted: 2023-07-20
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States