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OpenTrials
Completed

NCT Number: NCT00739700

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Correlation between NIBP and IABP. NIBP is measured in both upper arms, both wrists, both thighs, and both ankles.

    Time frame: All NIBP's are measured within 10 minutes.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Accuracy and Precision of Oscillometric Blood Pressure Monitoring in the Arm, Calf and Thighs of Medical ICU Patients When Compared to Invasive Arterial Blood Pressure Monitoring

Acronym: NIBP vs IABP

Important dates

Study start
2007
Primary completion
2009
Study completion
2016
First posted
Aug 22, 2008
Registry last updated
Nov 8, 2017

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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