Wearable Technology in Endoscopy

NCT05044104 | Completed Results FDA Device

• 1 other identifier: 21-007738
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Gastrointestinal Endoscopic Procedure with sedation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Wearable technology in endoscopic gastrointestinal procedures with sedation

EXPERIMENTAL

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

Interventions

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.

Also known as: Apple Watch Series 6, FitBit Versa

Wearable technology in endoscopic gastrointestinal procedures with sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy.
• Physical deformity, wound, or dressing preventing placement of a wearable device on the wrist.
• Allergy to aluminum, nickel or acrylate.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Limitations and Caveats

Limited number of arrhythmia events; Inconsistent accuracy of device reading; Device fit differed between patients

Results Point of Contact

• Title: Dr. Vinay Chandrasekhara
• Organization: Mayo Clinic

Chandrasekhara.Vinay@mayo.edu

207-284-2687

Study Officials

• Vinay Chandrasekhara, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2021
• First Posted: September 14, 2021
• Study Start: January 11, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 20, 2023
• Results First Posted: July 20, 2023

Record last verified: 2023-07

Locations

US (1)