Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

Hypertension Clinical Trial

Official title:

Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629535
• Other study ID #: 17-00884
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: September 10, 2019

Study information

• Verified date: January 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypotension

Intervention

Device:
• Non-invasive non-oscillometric blood pressure wristband 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.
Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during intervention for 30 minutes