Wearable Technology in Endoscopy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2022-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Wearable technology in endoscopic gastrointestinal procedures with sedation

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.

Group Type EXPERIMENTAL

Consumer-facing wearable smart watch

Intervention Type DEVICE

Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Apple Watch Series 6 FitBit Versa

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes