Blood Pressure, Surgery, Intensive Care Unit
Conditions
Keywords
Blood Pressure, BP, Surgery, Radial Artery Catheter
Brief summary
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
Detailed description
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.
Interventions
DEVICEViTrack
ViTrack is a continuous non-invasive wearable blood pressure cuff.
PROCEDURERadial artery catheterization
Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
Sponsors
Dynocardia, Inc
University of Massachusetts, Worcester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
None, patients are their own control.
Intervention model description
Single group design, patients are their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients between the ages of 18 - 90 years age who are undergoing any surgery or in the intensive care unit and require intra-arterial catheterization for continuous BP measurement. * Patients having elective surgeries. * Patients having emergent surgeries, but only if research staff can have appropriate time to review study with patient and obtain signature on fact sheet prior to administration of medications that could affect coherency. * Patients who are able to review, verbalize understanding, and sign fact sheet. If patient has a health care proxy (HCP) or legal guardian, study will be reviewed, and signature of HCP or legal guardian will be obtained.
Exclusion criteria
* Inability to obtain consent from the patient, HCP or legal guardian * Greater than 10% difference in BP measurements between both arms prior to surgery * Pregnant women * Prisoners * Inability to insert a radial artery catheter * Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator * Upper extremity arteriovenous haemodialysis shunt * Upper extremity amputation * Surgical position/draping precludes access to the wrist. * Wrist distortion or pain from arthritis * Prior trauma or surgery at the radial artery monitoring site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Diastolic Blood Pressure | Up to 24 Hours | 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. |
| Comparison of Systolic Blood Pressure | Up to 24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation | Up to 72 hours | Examining for local skin irritation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 21 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 69.4 Years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Up to 24 Hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Comparison of Diastolic Blood Pressure | 0.90 mmHg | Standard Deviation 5.97 |
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.
Time frame: Up to 24 Hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Study Participants | Comparison of Systolic Blood Pressure | 0.19 mmHg | Standard Deviation 5.7 |
Secondary
Skin Irritation
Examining for local skin irritation
Time frame: Up to 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Study Participants | Skin Irritation | 0 Participants |