Evaluation of a Non-invasive Cardiac Output Monitoring System.

NCT03178097 | Completed

• 1 other identifier: IN-OCT-01
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

There are different methods for measuring cardiac output (CO) completely non-invasive, which are used today. Two of these should be used in the study to examine the CO in an older group of patients (\> 65 years) undergoing major trauma surgery. The first method is the esCCOTM-technology by Nihon Kohden, the second uses the Volume Clamped Method via a finger-cuff by Nexfin Edwards life sciences. Both technologies work continuously and fully non-invasive. The measured data will be compared to established standard procedures like semi-invasive pulse contour analysis using the Flotrac-Vigileo system. The study should answer the following questions:

• How accurate and precise are the non-invasive methods? How large is the percentage deviation in comparison to the established standard?
• Are there any limitations of measuring accuracy regarding the age of the patient? The continuous hemodynamic monitoring of patients during surgery has recently changed from invasive and semi-invasive methods to completely non-invasive technologies. The accuracy and precision of this way of measuring cardiovascular parameters in comparison to the invasive standard is still controversial. Especially for older patient with atherosclerotic alteration of the blood vessels the utility of non-invasive monitoring systems is not shown yet. But principally this group with a high level of comorbidity might profit notably from less invasive procedures. This is the reason for the planed research.

Conditions

Surgery in Elderly Patients; Hemodynamics

Keywords

limitation in conventional monitoring

Outcome Measures

Primary Outcomes (1)

• cardiac output (CO)

  Comparison of cardiac output, utilizing cardiac index (CI), between the Volume Clamped Method via a finger-cuff (Nexfin Edwards Lifesciences) and the Flotrac-Vigileo (Edwards lifesciences) monitoring system.

  through study completion, an average of 1,5 years

Secondary Outcomes (2)

• arterial blood pressure

  through study completion, an average of 1,5 years

• stroke volume variation (SVV)

  through study completion, an average of 1,5 years

Eligibility Criteria

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

Study Population

Elderly patients older than 65 years who will participate in vascular or trauma surgery.

You may qualify if:

• Major surgery (elective or urgent) in vascular surgery and trauma surgery
• Patient´s rating according to ASA physical status classification system with 2-4
• Written consent by patient
• Age \> 65

You may not qualify if:

• ASA 5
• Patient requiring high doses of catecholamine already before surgery
• Cognitive or language barriers restricting informant consent of patient
• Denial of participation by the patient
• emergency surgery

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Universitätsklinikum Schleswig-Holstein Campus Kiel - Klinik für Anästhesiologie und Operative Intensivmedizin

Kiel, 24105, Germany

Location

Study Design

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

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 6, 2017
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)