N/A
Completed N=8
Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband
Source: ClinicalTrials.gov NCT03629535 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Average Error in Blood Pressure Readings — -1.5; 3.2 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Error in Blood Pressure Readings |
-1.5; 3.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03629535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.