Non-Invasive Blood Pressure (BP) Monitoring Compared to A-Line BP Monitoring (NIBP vs IABP)
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Purpose
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.
| Condition |
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Hemodynamics Blood Pressure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Accuracy and Precision of Oscillometric Blood Pressure Monitoring in the Calf and Thighs of Medical ICU Patients When Compared to Invasive Arterial Blood Pressure Monitoring |
- 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. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2007 |
| Groups/Cohorts |
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A
There is only one cohort of subjects, the critically ill. The NIBP will be correlated with the IABP in each subject.
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Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Medical Intensive Care Unit patients with intra-arterial blood pressure catheters will be enrolled. Blood pressure cuff measurements will be made in both arms and both legs.
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Arjun B Chatterjee, MD, MS | Wake Forest University |
| Principal Investigator: | Robert Chin, MD | Wake Forest University |
More Information
Publications:
| Responsible Party: | Arjun Chatterjee, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00739700 History of Changes |
| Other Study ID Numbers: | IRB00001777 |
| Study First Received: | August 20, 2008 |
| Last Updated: | February 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
hemodynamics blood pressure blood pressure monitors |
ClinicalTrials.gov processed this record on May 21, 2013