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

Completed

• Conditions: Blood Pressure

• Registration Number: NCT02009020
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-04
• Status Verified: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-07
• Last Update Submitted: 2013-12-07
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement	intraoperatively	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.

Trial Locations

Locations (1)

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology); 🇩🇪 Mainz, Germany