Trial Outcomes & Findings for Wearable Technology in Endoscopy (NCT NCT05044104)

NCT ID: NCT05044104

Last Updated: 2023-07-20

Results Overview

Number of tachycardia events recorded as defined as heart rate \> 100 bpm

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 292 participants
• Primary outcome timeframe: Anesthesia Duration, approximately 30 to 45 minutes
• Results posted on: 2023-07-20

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	292
Overall Study COMPLETED	292
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Age, Continuous	60.0 years n=292 Participants
Sex: Female, Male Female	173 Participants n=292 Participants
Sex: Female, Male Male	119 Participants n=292 Participants

PRIMARY outcome

Timeframe: Anesthesia Duration, approximately 30 to 45 minutes

Number of tachycardia events recorded as defined as heart rate > 100 bpm

Outcome measures

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Recorded Tachycardia Events Anesthesia Monitoring	9 Events
Recorded Tachycardia Events Smartwatch	3 Events
Recorded Tachycardia Events Smartwatch Accessories	22 Events

PRIMARY outcome

Timeframe: Anesthesia Duration, approximately 30 to 45 minutes

Number of bradycardia events recorded as defined as heart rate < 60 bpm

Outcome measures

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Recorded Bradycardia Events Anesthesia Monitoring	119 Events
Recorded Bradycardia Events Smartwatch	67 Events
Recorded Bradycardia Events Accessories	33 Events

PRIMARY outcome

Timeframe: Anesthesia Duration, approximately 30 to 45 minutes

Number of desaturation events recorded as defined as peripheral O2 saturation <88%

Outcome measures

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Recorded Desaturation Events Smartwatch	0 events
Recorded Desaturation Events Anesthesia Monitoring	91 events
Recorded Desaturation Events Smartwatch Accessories	71 events

PRIMARY outcome

Timeframe: Anesthesia Duration, approximately 30 to 45 minutes

Number of arrhythmia events recorded

Outcome measures

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Recorded Arrhythmia Events Anesthesia Monitoring	1 events
Recorded Arrhythmia Events Smartwatch	0 events
Recorded Arrhythmia Events Smartwatch accessories	0 events

PRIMARY outcome

Timeframe: Anesthesia Duration, approximately 30 to 45 minutes

Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute

Outcome measures

Measure	Patients Undergoing Gastrointestinal Endoscopy With Sedation n=292 Participants 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.
Recorded Tachypnea Anesthesia Monitoring	29 events
Recorded Tachypnea Smartwatch	0 events
Recorded Tachypnea Smartwatch accessories	0 events

Adverse Events

Patients Undergoing Gastrointestinal Endoscopy With Sedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vinay Chandrasekhara

Mayo Clinic

Phone: 207-284-2687

Email: Chandrasekhara.Vinay@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place