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

NCT02682615 | Withdrawn

• 1 other identifier: A138-15
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiac Output

Keywords

Cardiac Index; Noninvasive; esCCO; PiCCO; Thermodilution

Outcome Measures

Primary Outcomes (1)

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

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

  through study completion, an average of 1 year

Secondary Outcomes (1)

• 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 Arms (1)

requirement of norepinephrine

requirement of norepinephrine \<0,1 µg/kgKG/min versus ≥0,1 µg/kgKG/min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim of this study is the estimation of the agreement between esCCO™ and the transcardiopulmonal thermodilution technique (PiCCO®) using Bland-Altman-treatment. The 95%-confidence interval of the limits of agreement was selected for the design of the number of cases. At a number of cases by 100 you will get the width of 0,68 s (s: standard deviation of the differences of the measurement techniques). This is reasonable for the question (Bland and Altman 1986, you have to compare the recommendation of Bland: https://www.users.york.ac.uk/\~mb55/meas/sizemeth.htm).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

GERMANY - Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24109, Germany

Location

Study Officials

• Jochen Renner, PD Dr. med

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 15, 2016
• Study Start: August 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)