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

Blood Pressure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009020
• Other study ID #: 837.531.11 (8073)
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: December 7, 2013
• Start date: July 2012

Study information

• Verified date: December 2013
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
Germany	Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No