Wearable Technology in Endoscopy

A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05044104

Enrollment

292

Registered

2021-09-14

Start date

2022-01-11

Completion date

2022-09-01

Last updated

2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Gastrointestinal Endoscopic Procedure with sedation

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.

Interventions

DEVICEConsumer-facing wearable smart watch

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Patients Undergoing Gastrointestinal Endoscopy With Sedation Patients who underwent an endoscopic gastrointestinal procedure with sedation as part of standard of care who wore a consumer-facing wearable smart watch for the duration of the procedure.	292
Total	292

Baseline characteristics

Characteristic	Patients Undergoing Gastrointestinal Endoscopy With Sedation	—
Age, Continuous	60.0 years	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	173 Participants	—
Sex: Female, Male Male	119 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 292
other Total, other adverse events	0 / 292
serious Total, serious adverse events	0 / 292