Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients

Status Withdrawn

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02682615
Study type	Observational
Source	University of Schleswig-Holstein
Contact
Status	Withdrawn
Phase
Start date	August 1, 2017
Completion date	December 1, 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04604886` - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients	N/A
Completed	`NCT04044157` - Cardiac Output in Children During Anesthesia
Not yet recruiting	`NCT01678066` - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor	N/A
Completed	`NCT01001533` - Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation	N/A
Recruiting	`NCT04926220` - Dynamic Estimation of Cardiac Output in the Operating Room
Not yet recruiting	`NCT06007196` - Evaluation of Non-invasive Continuous Hemodynamic Measurement From Task Force CORE
Recruiting	`NCT05648279` - Personalized Hemodynamic Management in High-risk Major Abdominal Surgery	N/A
Recruiting	`NCT06090396` - Non-invasive Cardiac Index in Children
Completed	`NCT05508711` - Comparability of Transesophageal Echocardiography and FloTrac/Vigileo System Three Different Positions
Completed	`NCT02438228` - Cardiac Output by Nine Different Pulse Contour Algorithms	N/A
Withdrawn	`NCT00783679` - The Feasibility and Accuracy of Exhaled CO2 to Measure Cardiac Output in Ventilated Patients Without Tracheal Intubation	N/A
Completed	`NCT00996190` - Best Regimen for Phenylephrine Administration During Cesarean Section	Phase 4
Active, not recruiting	`NCT04465201` - The Smart Pump Study	N/A
Completed	`NCT05779683` - Caretaker in the Cardiovascular Intensive Care Unit (CVICU)
Completed	`NCT04112719` - Assessing Effects of Lateral Tilt on Cardiac Output Using a Non-invasive Technique
Recruiting	`NCT02156856` - Stroke Volume Analysis During Aortic Valve Replacement Trial	N/A
Recruiting	`NCT01781260` - Effect of Prone Position on Liver Blood Flow and Function	N/A
Terminated	`NCT00920569` - Recirculation, Oxygenator Blood Volume and Cardiac Output Measurements During Extracorporeal Membrane Oxygenation	N/A
Recruiting	`NCT06114147` - Cardiac Flow Measurements in Pregnant Women by Non Invasive Techniques	N/A
Completed	`NCT05365113` - Comparison of Hemodynamic Effects of Two Modalities of Alveolar Recruitment Maneuvers in Major Abdominal Surgery Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Non-invasive Cardiac Output Monitoring (esCCO™) in Critically Ill Patients Within ICU

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms