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| Name | Class |
|---|---|
| Dynocardia, Inc | INDUSTRY |
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To compare a noninvasive and continuous radial artery blood pressure measurements utilizing ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in patients undergoing surgery or those who are being cared for in the intensive care unit
The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical procedure or intensive care unit. This will allow us to compare BP readings between the non-invasive ViTrack device and the standard of care invasive intra-arterial catheters readings. Data collection from both the ViTrack and arterial catheter occur in the opposite wrists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wrist one | Experimental | Wrist one will have both the ViTrack wrist cuff on one wrist |
|
| Wrist Two | Active Comparator | Wrist two and the radial artery catheter in the opposite wrist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViTrack | Device | ViTrack is a continuous non-invasive wearable blood pressure cuff. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Diastolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively. | Up to 24 Hours |
| Comparison of Systolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively. | Up to 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Irritation | Examining for local skin irritation | Up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Scott, DO | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11137411 | Result | Heard SO, Lisbon A, Toth I, Ramasubramanian R. An evaluation of a new continuous blood pressure monitoring system in critically ill patients. J Clin Anesth. 2000 Nov;12(7):509-18. doi: 10.1016/s0952-8180(00)00201-4. |
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Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.
Data will become available following data analysis within 12 months of study completion and will remain available for up to 3 years.
Data will be accessed via secure methods outlined in a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Wrist one will have the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two with the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comparison of Diastolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively. | Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome DBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards. | Posted | Mean | Standard Deviation | mmHg | Up to 24 Hours |
|
Date of enrollment only
This device is non-invasive and has no inherent risk of serious adverse events or all-cause mortality
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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 | All Study Participants | Wrist one will have both the ViTrack wrist cuff on one wrist. ViTrack: ViTrack is a continuous non-invasive wearable blood pressure cuff. Wrist two and the radial artery catheter in the opposite wrist. Radial artery catheterization: Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Aaron Scott, DO | UMass Chan Medical School | 774-303-4156 | jamesaaron.scott@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2023 | Mar 28, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2023 | May 14, 2025 | SAP_002.pdf |
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Single group design, patients are their own control.
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None, patients are their own control.
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| Radial artery catheterization |
| Procedure |
Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery. |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| 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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| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Comparison of Systolic Blood Pressure | 255 time points compared across continuous blood pressure (mmHg) As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively. | Wrist 1, the ViTrack wrist cuff represents the experimental arm of the study. Wrist 2, the radial arterial catheter, represents the gold standard arterial blood pressure monitor that the ViTrack device is being compared to. The outcome SBP for the ViTrack device reports the mean error and standard deviation for the ViTrack device in comparison to the gold standard in alignment with the FDA standards. | Posted | Mean | Standard Deviation | mmHg | Up to 24 Hours |
|
|
|
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| Secondary | Skin Irritation | Examining for local skin irritation | Posted | Count of Participants | Participants | Up to 72 hours |
|
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be < 5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively |