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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05044104
Other study ID # 21-007738
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2022
Est. completion date September 1, 2022

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 292
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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