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

NCT ID: NCT02009020

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Brief Summary

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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

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Conditions

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Blood Pressure

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Verena Schnupp

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitaetsmedizin - Johannes Gutenberg University Mainz (Department of Anesthesiology)

Mainz, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19602972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19448207 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2868172 (View on PubMed)

Other Identifiers

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837.531.11 (8073)

Identifier Type: -

Identifier Source: org_study_id