Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Correlation of Estimated Continuous Cardias Output (esCCO) and Picco in Partial Liver Resection

This study has been completed.
Sponsor:
Collaborator:
Nihon Kohden Europe
Information provided by (Responsible Party):
Christoph Schramm, M.D., University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01443767
First received: September 26, 2011
Last updated: February 12, 2012
Last verified: February 2012

September 26, 2011
February 12, 2012
July 2011
November 2011   (final data collection date for primary outcome measure)
Correlation of esCCO and Picco in Partial Liver Resection [ Time Frame: Intraoperative (Measurement from induction of anaesthesia to extubation) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01443767 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Correlation of Estimated Continuous Cardias Output (esCCO) and Picco in Partial Liver Resection
Pilot Study to Examine the Correlation of 'Estimated Continuous Cardias Output' (esCCO) With Pulse Contour Analysis of the Arterial Waveform (Picco) in Partial Liver Resection

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.

The objective is to compare two methods of cardiac output measurement: the new non-invasive method called esCCO™ (by Nihon Kohden, Tokyo, Japan) and the established more invasive method PiCCO™ (by PULSION Medical Systems, Munich, Germany). esCCO™ is a completely non-invasive method that could provide a cardiac output measurement in a large range of patients because of an extremely low risk benefit balance. Thus the valuable information of cardiac output in combination with standard patient monitoring could be integrated in the assessment and clinical handling of a patients circulatory system.

In previous Japanese studies, esCCO™ was tested against the pulmonary artery catheter in patients undergoing heart surgery. Because of promising results in those studies, the validity of the method is now tested in patients scheduled for partial liver resection as a major visceral surgery intervention. Partial liver resection is a medium to high risk surgical intervention because of the extended blood supply of the organ. High and sudden blood loss can easily occur during the operation. Measurement period starts at the beginning of anesthesiologic induction and is continued until the extubation at the end of the intervention.

The algorithm for esCCO™ -measurement is integrated in an approved patient monitor that replaces the standard patient monitor during the measurement-period. The PiCCO™-device is added on the same rack and a cable connects the PiCCO™-device to the patient monitor. To assure maximum quality of the reference method, a thermodilution for PiCCO™-calibration is accomplished every 30 minutes.

In the study protocol, events like esCCO™ - and PiCCO™-calibration time, catheter positioning time, changes of the patient's position, ventilation settings, volume in- and output and drug administration, patients's data and diagnoses are logged. Vital parameters from the patient monitor including the PiCCO™-cardiac output values are recorded every second in real time on a study laptop mounted on the same rack as the patient monitor and the PiCCO™ device but separated electrically from the other devices.

A total of 30 patients shall be investigated in the study during a planned study time of approximately 6 months. The ethics committee of the University of Heidelberg gave their consent to the study (S-188/2011). The investigators will approximately receive 1080 data pairs when averaging the values every 5 minutes with a mean duration of the surgical procedure of 3 hours.

For statistical analysis, a Bland-Altman-test for multiple values in one patient, a t-test for depending values, correlation graphics and a regression equation will be performed.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

adult patients scheduled for partial liver resection

Continuous Cardiac Output
Not Provided
Partial liver resection
Adult patients scheduled for elective partial liver resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
November 2011
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • no written consent
  • continuous severe cardiac arrhythmias
  • cardiac pacemaker
  • intraaortal balloon pump
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01443767
S188/2011
No
Christoph Schramm, M.D., University of Heidelberg
Heidelberg University
Nihon Kohden Europe
Study Chair: Konstanze Plaschke, Professor Heidelberg University
Principal Investigator: Christoph Schramm, M.D. Heidelberg University
Heidelberg University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP