Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive non-oscillometric blood pressure wristband device

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.

Device

Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control

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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Aug 14, 2018
Registry last updated: Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed