Trial document




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  DRKS00005619

Trial Description

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Title

Prospective, single-center, open clinical study to compare two methods (transesophageal echocardiography (TOE), Electric Kardiometrie® (ICON®)) to determine the contractility of the heart in adult intensive care patients.

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Trial Acronym

Contractility 2

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URL of the Trial

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Brief Summary in Lay Language

So far, we routinely use special method for the monitoring of cardiovascular function (continuous electrocardiogram (temporary or permanent record of the sum of the electrical activity of the heart), arterial blood pressure measurement (measurement directly in the artery), transesophageal echocardiography (ultrasound investigation in which an endoscope with a built-in transducer is inserted into the esophagus)) in intensive care patients in the HELIOS Klinikum Krefeld. The echocardiography is one of the essential diagnostic tools for assessing cardiac surgical patients. It allows quick and minimally invasive (tissue infringing medical diagnostics or therapeutics) the precise measurement of a variety of parameters. In addition, it is ideally suited both for diagnosing the emergence of a cardiac failure as well as to select the appropriate therapy, its control and for the early detection of complications of the measures carried out. In particular, in diseases of the atria and the cardiac valves, as well as for the assessment of cardiac function, this investigation is the method of choice. This method is used in our study as the comparison method.
After approval of the ethics committee, we compared the values for contractility (ability of organs and tissues to contract) measured with this method with those that we have measured using the electrical Kardiometrie (ICON®) at 50 intensive care patients. The electrical Kardiometrie allows continuous non-invasive monitoring of cardiovascular function. The available monitors measure the changes in electrical bioimpedance during the cardiac cycle and then calculate a variety of parameters. Therefore four standard ECG electrodes attached to the left side of the neck and on the lower chest. A high frequent low amplitude alternating current is introduced via the outer electrodes in the direction of body axis to the chest. The resulting induced voltage is measured across the two inner electrodes. The ratio of the incorporated current and the measured voltage is equal to the electrical conductivity of the thorax, which characteristic changes during a cardiac cycle. From the implementation of the planned investigation, we hope to shed light on whether this less expensive and less invasive ICON ® method, can determine the contractility of the heart just as valid and precisely as the current gold standard (TEE ) (validation of test intervention).
By using the ICON® system monitoring of cardiovascular functions may be performed faster, less invasive, with fewer complications and therefore less stressful for patients. One reason for this is the lack of necessity to introduce an endoscope into the esophagus. The risks and complications (tooth decay, vocal cord damage, esophageal injury) associated with the process accounts. In addition, the necessary equipment is very expensive and the measured values are very dependent on the examiner.

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Brief Summary in Scientific Language

The perioperative mortality and morbidity of surgical patients is determined by their preoperative health status and complications that are associated with the performed procedures. In particular cardiac (heart failure, heart valve diseases) and pulmonary pre-existing conditions limit their physiological compensation mechanisms and are therefore of crucial importance, and in part by limiting to their outcome. As a result of inadequate cardiac output, but also of hyper-and hypovolemia, there is a reduction in the perfusion pressure to a reduced perfusion and thus to an insufficient supply of oxygen to the organs (DO2 ), from which then a oxygen debt with the risk of hypoxia and multiple organ failure results. A balanced perioperative catecholamine and fluid management with the objectives intravascular normovolemia and sufficient supply of oxygen, therefore, improves the outcome. The simple and valid measurement of the determinants of cardiovascular function (preload and afterload, contractility) is crucial when it comes to the detection and treatment of conditions which cause hypoperfusion and thus affect the prognosis of the patients. The assessment of cardiac functions (myocardial contractility , ejection fraction ( EF), flaps morphology and function) and the volume status in intensive care patients in our hospital, is usually done discontinuous by means of transesophageal echocardiography (TOE). For the determination of left ventricular function echocardiography is even the gold standard. For optimal control of a balanced perioperative catecholamine and fluid management, the use of TOE is not suitable (continuous measurement is not possible invasiveness of the procedure). The electrical Kardiometrie (ICON ®) allows continuous non-invasive measurement of contractility, cardiac and stroke volume. The available monitors measure using four standard surface ECG electrodes, the changes in thoracic electrical bioimpedance ( TEB) during the cardiac cycle and calculate so in addition to the stroke volume (SV), contractility (contractility index (ICON®)) and various other parameters.
In the course of intensive care of surgical patients measurements of various hemodynamic parameters for controlling a differentiating volume and catecholamine are repeatedly required. This is done at the current time intermittently or continuously by means of TOE or PiCCO®. In situations where the monitoring of hemodynamics using this method is difficult or impossible possible (not to establish, initial assessment in the emergency room) well-functioning alternative systems would be desirable. If it turns out that the accuracy and suitability of the ICON ® system is comparable to those of the previous standard method (TEE), it could be replace this in some areas and it can expand the former not always appropriate hemodynamic monitoring.
The aim of our investigation is to find out whether the index of the myocardial contractility ascertained with the ICON® system is as precisely as the determination by slice summation method modified after Simpson by TEA to determine the contractility (validation of the index of the myocardial contractility, ICON®). In addition, it is checked whether this is possible with the ICON® system, as precise as with the TOE (validation of the ICON® system).

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Organizational Data

  •   DRKS00005619
  •   2014/01/07
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  •   yes
  •   Approved
  •   2013352, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   I97 -  Postprocedural disorders of circulatory system, not elsewhere classified
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Interventions/Observational Groups

  •   Arm 1 - Determination of cardiac contractility in adult intensive care patients using transesophageal echocardiography (TEE) (control group) and electrical Kardiometrie® (ICON®) (intervention group).
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Difference between the index of myokardial contractility measured with the compared measurement method (electric Kardiometrie®) and the value determined by means of TEE.

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Secondary Outcome

• time required from the beginning of the establishment of the measurement procedures pending first readings.
• complication of the measurement method used.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/01/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Planned determining the contractility of the heart in adult intensive care patients.
• Written informed consent of the patient to participate.
• Age> 18 years of age.

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Exclusion Criteria

• ASA> 4 or life expectancy of the test subscriber is less than the test duration.
• Participation in another interventional clinical trials.
• diseases or disorders that participation in this clinical trial rule by investigator judgment (eg located in operational support systems (IABP, MECC), hemodynamic instability, heart valve diseases).

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Addresses

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    • HELIOS Klinikum Krefeld
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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    • HELIOS Klinikum Krefeld
    • Mr.  Dr. med.  Patrick  Braß 
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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    • HELIOS Klinikum Krefeld
    • Mr.  Dr. med.  Patrick  Braß 
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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Sources of Monetary or Material Support

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    • HELIOS Klinikum Krefeld
    • Lutherplatz 40
    • 47800  Krefeld
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.