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)

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Key information

Conditions

Blood Pressure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
First posted: Dec 11, 2013
Registry last updated: Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed