NCT00739700

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 8, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

August 20, 2008

Last Update Submit

November 6, 2017

Conditions

Keywords

hemodynamicsblood pressureblood pressure monitors

Outcome Measures

Primary Outcomes (1)

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

    All NIBP's are measured within 10 minutes.

Study Arms (1)

A

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Arterial blood pressure line

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (5)

  • 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.

    PMID: 10708169BACKGROUND
  • 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.

    PMID: 12626986BACKGROUND
  • 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.

    PMID: 14608157BACKGROUND
  • 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.

    PMID: 20890190BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Arjun B Chatterjee, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2016

Last Updated

November 8, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will share

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.

Locations