Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

Not Applicable

Completed

• Conditions: Hypertension; Hypotension
• Interventions: Device: Non-invasive non-oscillometric blood pressure wristband device; Device: Invasive intra-arterial blood pressure monitors.

• Registration Number: NCT03629535
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2019-04-01
• Primary Completion: 2019-09-10
• Study Completion: 2019-09-10
• Status Verified: 2021-01
• Results First Submitted: 2021-01-11
• Results First Submitted QC: 2021-01-29
• Last Update Submitted: 2021-01-29
• Results First Posted: 2021-02-02
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients in SICU	Non-invasive non-oscillometric blood pressure wristband device	Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.
Patients in SICU	Invasive intra-arterial blood pressure monitors.	Patients in the SICU with an intra-arterial blood pressure monitor already in place will be considered as subjects.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States