Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively

Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med 2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz technique, a non-invasive measurement device is now available commercially. In this study, the reference technique based on arterial measurement and a respiratory variation monitor (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1: 307-10)

Study Overview

• Status: Completed
• Conditions: Blood Pressure

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany, 55131
    • Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective abdominal or urological surgery

Description

Inclusion Criteria:

• Age > 18 and < 80 years old
• Written informed consent obtained
• Patients scheduled for elective urological or abdominal surgery procedures in supine position
• qualifying for arterial line

Exclusion Criteria:

• pregnancy
• cardiac insufficiency (NYHA 4, EF < 25 %)
• coronary artery disease (CCS 4)
• coagulopathy
• symptoms of infection or sepsis
• malignant hyperthermia
• absence of sinus rhythm
• BMI > 30
• M. Raynaud

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement	Systolic, diastolic, mean blood pressure and difference in pulse pressure are measured intraoperatively with a non-invasive device and the reference technique. The values are compared using Bland-Altmann Analysis.	intraoperatively

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
• Pestel G, Fukui K, Hartwich V, Schumacher PM, Vogt A, Hiltebrand LB, Kurz A, Fujita Y, Inderbitzin D, Leibundgut D. Automatic algorithm for monitoring systolic pressure variation and difference in pulse pressure. Anesth Analg. 2009 Jun;108(6):1823-9. doi: 10.1213/ane.0b013e3181a2a8bf.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 7, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 7, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 837.531.11 (8073)