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

NCT ID: NCT00739700

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Pressure

Keywords

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hemodynamics blood pressure blood pressure monitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arjun B Chatterjee, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Bur A, Hirschl MM, Herkner H, Oschatz E, Kofler J, Woisetschlager C, Laggner AN. Accuracy of oscillometric blood pressure measurement according to the relation between cuff size and upper-arm circumference in critically ill patients. Crit Care Med. 2000 Feb;28(2):371-6. doi: 10.1097/00003246-200002000-00014.

Reference Type BACKGROUND
PMID: 10708169 (View on PubMed)

Bur A, Herkner H, Vlcek M, Woisetschlager C, Derhaschnig U, Delle Karth G, Laggner AN, Hirschl MM. Factors influencing the accuracy of oscillometric blood pressure measurement in critically ill patients. Crit Care Med. 2003 Mar;31(3):793-9. doi: 10.1097/01.CCM.0000053650.12025.1A.

Reference Type BACKGROUND
PMID: 12626986 (View on PubMed)

Davis JW, Davis IC, Bennink LD, Bilello JF, Kaups KL, Parks SN. Are automated blood pressure measurements accurate in trauma patients? J Trauma. 2003 Nov;55(5):860-3. doi: 10.1097/01.TA.0000092686.91877.DE.

Reference Type BACKGROUND
PMID: 14608157 (View on PubMed)

Chatterjee A, DePriest K, Blair R, Bowton D, Chin R. Results of a survey of blood pressure monitoring by intensivists in critically ill patients: a preliminary study. Crit Care Med. 2010 Dec;38(12):2335-8. doi: 10.1097/CCM.0b013e3181fa057f.

Reference Type BACKGROUND
PMID: 20890190 (View on PubMed)

DePriest KL, Cauthen CG, Perry CD, Blair RA, Chatterjee A, Bowton D, Chin R. Do oscillatory blood pressure measurements in upper and lower extremities correlate in patients in the intensive care unit? Chest. 2008; 134(4_Meeting Abstracts): 119001.

Reference Type BACKGROUND

Other Identifiers

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IRB00001777

Identifier Type: -

Identifier Source: org_study_id