An interventional study of Non-invasive non-oscillometric blood pressure wristband device and Invasive intra-arterial blood pressure monitors. in Hypotension and Hypertension, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Exclusion Criteria:
Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.
Device: Non-invasive non-oscillometric blood pressure wristband device · Device: Invasive intra-arterial blood pressure monitors.
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.
Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
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
| Milestone | Patients in SICU |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| mmHg | Patients in SICU |
|---|---|
| Systolic | -1.5 ± 6.3 |
| Diastolic | 3.2 ± 6.0 |
Collected over during intervention for 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients in SICU | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Patients in SICU |
|---|---|
| Mean | 61.6 ± 16.4 |
| Sex: Female, Male(Participants) | Patients in SICU |
|---|---|
| Female | 5 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Patients in SICU |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | Patients in SICU |
|---|---|
| United States | 8 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Sap
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