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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02009020

Enrollment

Registered

2013-12-11

Start date

2012-07-31

Completion date

Unknown

Last updated

2013-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

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)

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement	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.

Countries

Germany

Outcome results