N/A
N=292
Wearable Technology in Endoscopy
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05044104 ↗Enrolled (actual)
292
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Recorded Tachycardia Events — 9; 3; 22 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Consumer-facing wearable smart watch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recorded Tachycardia Events |
9; 3; 22 | — |
| PRIMARY Recorded Bradycardia Events |
119; 67; 33 | — |
| PRIMARY Recorded Desaturation Events |
91; 0; 71 | — |
| PRIMARY Recorded Arrhythmia Events |
1; 0; 0 | — |
| PRIMARY Recorded Tachypnea |
29; 0; 0 | — |
Summary
Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05044104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.