Hypertension, Hypotension
Conditions
Brief summary
The primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. In an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. Blood pressure readings will be gathered and compared.
Interventions
DEVICENon-invasive non-oscillometric blood pressure wristband device
The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.
DEVICEInvasive intra-arterial blood pressure monitors.
Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted to the Surgical Intensive Care Unit who are already fitted with an invasive Arterial Line (A- Line) are eligible for the trial, and no volunteers candidates for an A Line are requested.
Exclusion criteria
* Within the candidate group of individuals whose procedure in the hospital requires an A-Line, the wristband may not, for various reasons, produce a clean signal. This is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). Such candidates will be excluded from admission to the study. * All data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmHg (2, 67 kPa) or if the invasive reference diastolic range is more than 12 mmHg (1, 6 kPa) in any single determination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Error in Blood Pressure Readings | during intervention for 30 minutes | If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination. The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic & Diastolic) and determination for each patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients in SICU Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.
Non-invasive non-oscillometric blood pressure wristband device: The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.
Invasive intra-arterial blood pressure monitors.: Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Patients in SICU |
|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 16.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Average Error in Blood Pressure Readings
If the value obtained from the LiveMetric determination lied within the range of the reference BP, an error of 0 mm Hg (0kPa) was assigned to this determination. If the value obtained from the LiveMetric determination lies outside the range of the reference BP, the value of the determination from the adjacent limit of the range of the variation of BP was subtracted. That difference represents the error for this determination. The arithmetic mean of the error is calculated and its experimental standard deviation from the errors of each recording for each BP value (Systolic & Diastolic) and determination for each patient.
Time frame: during intervention for 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in SICU | Average Error in Blood Pressure Readings | Systolic | -1.5 mmHg | Standard Deviation 6.3 |
| Patients in SICU | Average Error in Blood Pressure Readings | Diastolic | 3.2 mmHg | Standard Deviation 6 |