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

NCT02009020 | Completed

• 1 other identifier: 837.531.11 (8073)
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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)

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective abdominal or urological surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, 55131, Germany

Location

Related Publications (3)

• 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.

  PMID: 19602972 BACKGROUND

• 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.

  PMID: 19448207 BACKGROUND

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 BACKGROUND

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 11, 2013
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

DE (1)