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OpenTrials
Completed

NCT Number: NCT02009020

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

  1. 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.

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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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