Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02009020
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: