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

N/ACompletedNCT02009020

Johannes Gutenberg University Mainz26 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Blood Pressure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Outcomes

Primary Outcomes

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.

Time frame: intraoperatively