Skip to main content
Clinical Trials/NCT02682615
NCT02682615
Withdrawn
Not Applicable

Cardiac Output Monitoring System (esCCO™) in Comparison to Transcardiopulmonal Thermodilution Technique (PiCCO®) in Critically Ill Patients Within Interdisciplinary Surgical Intensive Care Units

University Hospital Schleswig-Holstein1 site in 1 countryAugust 1, 2017
ConditionsCardiac Output

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Output
Sponsor
University Hospital Schleswig-Holstein
Locations
1
Primary Endpoint
Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®)
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief Summary

Evaluation of a non-invasive technique to measure cardiac output (esCCO™) with the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®). Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease - APACHE II score).

Detailed Description

The measurements have to estimate the agreement of esCCO™ and PiCCO® related to the cardiac output (cardiac index). It should consult a comparison of methods between a complete non-invasive cardiac output monitoring method (esCCO™) and the transcardiopulmonal thermodilution technique (PiCCO®). The accuracy shall carve out as well as the power of agreement of both measurement methods. It takes two simultaneous measurements at a time of critically ill patients at interdisciplinary surgical intensive care units. Furthermore the force of the major variables (1. requirement of norepinephrine and 2. APACHE II-score) to the estimators shall be realized. esCCO™ vs. (PiCCO®) This research shall include 100 patients which have to undergo a complex intensive care treatment within predefined therapy intentions. During a daily screening within the interdisciplinary surgical intensive care units of the Universitätsklinikum Schleswig-Holstein, Campus Kiel it will be opted for the inclusion of the patients. Points of time x \[x ε M and M = {1, 2, 3, 4}\] - two test series (measurement 1 and 2). According to the ability of the patient to the research the predefined point of time number 1 will be supposed (point of time number 1: inclusion criterium). The predefined point of time number 2 will be supposed if the therapy concept is planned or changed. The point of time number 3 is defined as the re-evaluation in the course of changed therapy conceptions. If the medical practitioner team decides to renounce the PiCCO-system, the predefined point of time number 4 has arrived. The requirement of norepinephrine will be registered in every measurement (1 and 2). The APACHE II-score will be surveyed each point of time x (see above). The remaining treatment of the patients will be performed in the conventional way by the medical practitioner team within the interdisciplinary surgical intensive care units.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
December 1, 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Dr. Jochen Renner

PD Dr.

University Hospital Schleswig-Holstein

Eligibility Criteria

Inclusion Criteria

  • The extended haemodynamic monitoring procedure PiCCO® has already been established due to the clinical decision making of the medical practitioner team

Exclusion Criteria

  • atrial fibrillation
  • cardiac arrhythmias
  • cardiac pacemaker
  • intraaortic counterpulsation
  • pericardial tamponade
  • age \< 18 years
  • missing or incorrect patient consent form

Outcomes

Primary Outcomes

Comparison between esCCOTM and the transcardiopulmonal thermodilution technique (PiCCO®)

Time Frame: through study completion, an average of 1 year

Comparison of cardiac output, utilizing cardiac index (CI), between (esCCO™) and the "clinical goldstandard" of the transcardiopulmonal thermodilution technique (PiCCO®)

Secondary Outcomes

  • Effect of different potential interference factors to the accuracy of measurement (changing concentration of norepinephrine, generally severity of the basic disease)(through study completion, an average of 1 year)

Study Sites (1)

Loading locations...

Similar Trials