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Clinical Trials/NCT03629535
NCT03629535
Completed
Not Applicable

Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

NYU Langone Health1 site in 1 country8 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
NYU Langone Health
Enrollment
8
Locations
1
Primary Endpoint
Average Error in Blood Pressure Readings
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
September 10, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Average Error in Blood Pressure Readings

Time Frame: 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.

Study Sites (1)

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