AzTrials
AzTrials

Continuous Cardiac OutputNCT01443767

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

An observational study of Continuous Cardiac Output, run by Heidelberg University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Continuous Cardiac Output
How many people
27 participants
Where
1 siteGermany
Study dates
Jul 2011to Nov 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: adult patients scheduled for partial liver resection

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • University of Heidelberg

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: 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.

Read the detailed description

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.

Keywords
Cardiac Output, esCCO, Pulse Wave Transit Time, PiCCO, Pulse Contour Analysis, Non-invasive Monitoring, Partial Liver Resection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01443767
Study groupRoleWhat they receive
Partial liver resectionAdult patients scheduled for elective partial liver resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of esCCO and Picco in Partial Liver Resection

    Measured: Intraoperative (Measurement from induction of anaesthesia to extubation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01443767
Sponsor's protocol ID
S188/2011
Status last verified
Feb 2012
First submitted
26 Sep 2011
Last updated
14 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Continuous Cardiac Output, run by Heidelberg University at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of esCCO and Picco in Partial Liver Resection (time frame: Intraoperative (Measurement from induction of anaesthesia to extubation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in