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

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ClinicalTrials.gov Identifier: NCT00739700
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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 or disease
Blood Pressure

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.

Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2016

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



Primary Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739700


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Arjun B Chatterjee, MD, MS Wake Forest University Health Sciences

Publications:
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00739700     History of Changes
Other Study ID Numbers: IRB00001777
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A requestor must have local IRB approval and funding to support a request of this data. It will be provided de-identified and shared authorship is required.

Keywords provided by Wake Forest University Health Sciences:
hemodynamics
blood pressure
blood pressure monitors