A prospective, nonrandomized, noninterventional study to compare Nexfin CO-trek cardiac output with thermodilution cardiac output

ISRCTN ISRCTN91147138
DOI https://doi.org/10.1186/ISRCTN91147138
Secondary identifying numbers Protocol Revision C/ METC 2013_068 / NL44270.018.13
Submission date
03/07/2015
Registration date
10/09/2015
Last edited
12/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Cardiac output is the amount of blood the heart pumps into the circulation per minute. In patients scheduled for cardiac (heart) surgery, cardiac output is measured using a catheter (tube) in the pulmonary artery. This is an invasive method. This study aims to compare the invasive method with a completely non-invasive method of cardiac output measurement. The non-invasive method uses a single air-inflatable cuff around one of the fingers. The non-invasive measurement has no potential harmful side effects.

Who can participate?
Patients aged over 18 scheduled for cardiac surgery.

What does the study involve?
The cuff will be applied directly before the operation starts, but before you are being anesthetized. We compare the new method against the standard method of measuring cardiac output during operations. The standard method involves placement of a special central venous line. In patients undergoing cardiac surgery, the latter method is used as the standard of care. Therefore the only procedure the this study involves is the extra measurement using the finger cuff.

What are the possible benefits and risks of participating?
Participation in this study has no potential benefits for you as a patient. Because the new method is completely non‐invasive, participation to this study has very little associated risks. The only adverse effect of the finger cuff is a temporarily blue‐coloring of the fingertip. This is completely harmless and the color of the finger immediately normalizes when the cuff is removed.

Where is the study run from?
Academic Medical Center (Netherlands), VU Medical Center (Netherlands), Cooper University Hospital (USA).

When is the study starting and how long is it expected to run for?
November 2013 to February 2015.

Who is funding the study?
Edwards Lifesciences (USA).

Who is the main contact?
Dr Niek Sperna Weiland

Contact information

Dr Niek Sperna Weiland
Scientific

Meibergdreef 9
Amsterdam-Zuidoost
1105AZ
Netherlands

Study information

Study designObservational multicenter study
Primary study designObservational
Secondary study designProspective nonrandomized noninterventional
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format. Please contact the details below to request a patient information sheet
Scientific titleA prospective, nonrandomized, noninterventional study to compare Nexfin CO-trek cardiac output with thermodilution cardiac output
Study objectivesThe primary objective of this study is to show the accuracy of Cardiac Output measurement with the ccNexfin by assessment of agreement between ccNexfin and Cardiac Output measurement by pulmonary thermodilution using a Pulmonary Artery Catheter. To demonstrate this, the difference between the two methods must be smaller than the minimum difference considered as clinically significant (within 0.6 liters per minute difference).
Ethics approval(s)Medisch Ethische Toetsingscommissie Academisch Medisch Centrum, internal reference number METC 2013_068
Health condition(s) or problem(s) studiedCardiac output measurement
InterventionPRIOR TO PROCEDURE
The standard pre‐evaluation will include:
1. Informed consent
2. Screening for inclusion and exclusion criteria
3. Basic medical history.
4. Baseline information, findings, and results will be entered in the eCRFs from the source documents including:
4.1. General Information (subject ID number, date & time of consent, age/gender/height/weight)
4.2. Clinical Information (ASA class, relevant medical history, use of medication, cardiac rhythm, reason for surgery)
For subjects who are enrolled in the study (signed an informed consent) but who do not undergo the required measurements, the eCRFs will not be completed. The site must retain the subject’s informed consent. Verification that the subject signed the consent will occur during an on‐site monitoring visit.

DURING PROCEDURE
The CO comparison will be made in the period before the extracorporeal circulation and preferably in baseline as well as in Trendelenburg/reverse Trendelenburg position as clinically required. The following items will be performed:
1. The measurements are performed in the OR during anesthesia
2. ccNexfin cuff application to the appropriate finger of the arm with the arterial line
3. Start of ccNexfin measurement
4. The Investigator will perform intermittent TD measurements as required. Pre‐loading status (baseline, [reverse] Trendelenburg) will be noted.
5. Marking of this period on the ccNexfin recording in order to be able to pair TD measurements with beats recorded with the ccNexfin. Pairing of the cardiac cycles for the analyses is described in Appendix 6.
6. General Information (subject ID number, time of surgery start, study/reference device information and measurement sites)
7. Clinical Information as available (fluid administration, fluid loss, fluid balance, vasoactive/inotropic medications administered, mechanical ventilation settings [tidal volume, PEEP & FiO2]; all with time instants).

POST‐PROCEDURE
Study is complete when cardiopulmonary bypass is initiated or when the heart or vascular system is physically manipulated. Devices will be removed from the patients at the end of the surgical procedure
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe primary study endpoint is the acquisition of the cardiac output values of the two devices to meet an acceptance criterion of Bias < 0.6 liters per minute.
Secondary outcome measuresThe secondary study endpoints (and acceptance criteria) are:
1. The comparability of both methods as determined by Bland-Altman analysis (Bias < 0.6, Percentage Error < 40.4)
2. The precision of Nexfin CO-trek versus TD (no acceptance criterion)
3. The Pearson correlation coefficient of the CO pairs of the two methods (no acceptance criterion)
Overall study start date26/11/2013
Completion date12/02/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsMaximally 60
Total final enrolment55
Key inclusion criteria1. Subjects must be at least 18 years of age
2. Subjects must give signed written informed consent
3. Subjects' height and weight must be accurately obtained prior to study start
Key exclusion criteria1. Aortic or tricuspid valve regurgitation
2. Aortic stenosis or aneurysms
3. History of uncontrolled cardiac arrhythmia
4. Any peripheral vascular disease or conditions such as Raynaud's disease or Buerger's disease
5. Insufficient perfusion of the digits
6. Inability to place the finger cuff appropriately due to subject anatomy or condition
7. Known pregnancy
8. Patients being treated with an intra-aortic balloon pump
9. Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
Date of first enrolment11/12/2013
Date of final enrolment14/12/2014

Locations

Countries of recruitment

  • Netherlands
  • United States of America

Study participating centres

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
VU Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Cooper University Hospital
1 Cooper Plaza
Camden, NJ
08103
United States of America

Sponsor information

Edwards Lifesciences LLC
Industry

One Edwards Way
Irvine, CA
92614 USA
United States of America

ROR logo "ROR" https://ror.org/04jhyte11

Funders

Funder type

Industry

Edwards Lifesciences
Government organisation / For-profit companies (industry)
Alternative name(s)
Edwards, Edwards Lifesciences Corporation, Edwards Lifesciences Corp., Edwards Lifesciences LLC, ELC
Location
United States of America

Results and Publications

Intention to publish date30/03/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/04/2018 12/05/2021 Yes No

Editorial Notes

12/05/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.