Accuracy of Non-invasive Non-oscillometric Blood Pressure Wristband

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Hypotension
Hypertension

Treatments

Device: Non-invasive non-oscillometric blood pressure wristband device
Device: Invasive intra-arterial blood pressure monitors.

Study type

Interventional

Funder types

Other

Identifiers

NCT03629535
17-00884

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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