NCT01443767

Brief Summary

The purpose of this study is to determine the measuring accuracy of the truly non-invasive method estimated continuous cardiac output (esCCO) against the reference method pulse contour analysis of the arterial waveform (Picco) in partial liver resection. esCCO is calculated using the pulse wave transit time, which is defined as the time between the R-wave of the ECG and a 30% increase of the differentiated pulseoximetry waveform.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

September 26, 2011

Last Update Submit

February 12, 2012

Conditions

Continuous Cardiac Output

Keywords

Cardiac OutputesCCOPulse Wave Transit TimePiCCOPulse Contour AnalysisNon-invasive MonitoringPartial Liver Resection

Outcome Measures

Primary Outcomes (1)

  • Correlation of esCCO and Picco in Partial Liver Resection

    Intraoperative (Measurement from induction of anaesthesia to extubation)

Study Arms (1)

Partial liver resection

Adult patients scheduled for elective partial liver resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients scheduled for partial liver resection

You may qualify if:

  • written consent
  • patient scheduled for partial liver resection
  • sinus rhythm

You may not qualify if:

  • no written consent
  • continuous severe cardiac arrhythmias
  • cardiac pacemaker
  • intraaortal balloon pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

Study Officials

  • Konstanze Plaschke, Professor

    Heidelberg University

    STUDY CHAIR

  • Christoph Schramm, M.D.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2011

First Posted

September 30, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

DE(1)