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Non-invasive Blood Pressure (BP) Monitoring Compared to A-Line BP Monitoring (NIBP vs IABP)

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Completed

Conditions

Blood Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT00739700
IRB00001777

Details and patient eligibility

About

Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the standard of care in the medical intensive care unit. There is little data to support this clinical normalization of deviance. This study aims to correlate NIBP with IABP.

Full description

It has become standard practice in inpatient and intensive care settings to monitor systolic, diastolic and mean arterial blood pressure by oscillometric technique. Several studies have confirmed the accuracy and precision of the oscillometric technique in ambulatory patients at both the level of the brachial and radial arteries. Multiple clinical research studies have demonstrated that when blood pressures (systolic, diastolic and mean arterial pressures) determined by non-invasive blood pressure monitors (NIBP) from various manufacturers are compared to direct invasive arterial pressure monitors, the two values are on average within 5 mm Hg of each other. There is limited data in critically ill patients. To date, there are no studies evaluating the accuracy or precision of these devices in intensive care patients for alternative sites (calf, thigh). In addition, there are no large clinical studies evaluating oscillometric NIBP monitoring in a complex medical intensive care population with varying hemodynamics. The goal of this study is to validate the oscillometric technique in measurement of blood pressure in the calf and thigh regions when compared to a gold standard. We may also be able to evaluate more specifically which situations for our patient population the blood pressure will be accurately portrayed as compared with the arterial pressure tracing. It has possible clinical value in either validating non-invasive blood pressure monitoring and eliminating/decreasing the need for invasive arterial blood pressure monitoring. Our hypothesis is that NIBP in the medical intensive care patients is highly variable and not a reliable means of arterial blood pressure monitoring.

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Arterial blood pressure line

Exclusion criteria

  • Lack of arms and legs for cuff pressures
  • Medical or surgical indication that might prevent use of blood pressure cuffs

Trial design

116 participants in 1 patient group

A
Description:
There is only one cohort of subjects, the critically ill. The NIBP will be correlated with the IABP in each subject.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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