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Researchers are assessing the accuracy and safety of wearable technology in subjects undergoing endoscopic gastrointestinal procedures with sedation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wearable technology in endoscopic gastrointestinal procedures with sedation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumer-facing wearable smart watch | Device | Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation. |
| Measure | Description | Time Frame |
|---|---|---|
| Recorded Tachycardia Events | Number of tachycardia events recorded as defined as heart rate > 100 bpm | Anesthesia Duration, approximately 30 to 45 minutes |
| Recorded Bradycardia Events | Number of bradycardia events recorded as defined as heart rate < 60 bpm | Anesthesia Duration, approximately 30 to 45 minutes |
| Recorded Desaturation Events | Number of desaturation events recorded as defined as peripheral O2 saturation <88% | Anesthesia Duration, approximately 30 to 45 minutes |
| Recorded Arrhythmia Events | Number of arrhythmia events recorded | Anesthesia Duration, approximately 30 to 45 minutes |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinay Chandrasekhara, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recorded Tachycardia Events | Number of tachycardia events recorded as defined as heart rate > 100 bpm | Posted | Number | Events | Anesthesia Duration, approximately 30 to 45 minutes |
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Adverse events were collected from baseline to end of study participation for a total of approximately 14 days on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limited number of arrhythmia events; Inconsistent accuracy of device reading; Device fit differed between patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vinay Chandrasekhara | Mayo Clinic | 207-284-2687 | Chandrasekhara.Vinay@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 4, 2022 | Jun 15, 2023 | Prot_SAP_000.pdf |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Recorded Bradycardia Events | Number of bradycardia events recorded as defined as heart rate < 60 bpm | Posted | Number | Events | Anesthesia Duration, approximately 30 to 45 minutes |
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| Primary | Recorded Desaturation Events | Number of desaturation events recorded as defined as peripheral O2 saturation <88% | Posted | Number | events | Anesthesia Duration, approximately 30 to 45 minutes |
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| Primary | Recorded Arrhythmia Events | Number of arrhythmia events recorded | Posted | Number | events | Anesthesia Duration, approximately 30 to 45 minutes |
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| Primary | Recorded Tachypnea | Number of tachypnea events recorded as defined as respiratory rate >18 breaths per minute | Posted | Number | events | Anesthesia Duration, approximately 30 to 45 minutes |
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| 292 |
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| 292 |
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