Comparison of Cardiac Index (CI) Measurements Performed With Different Methods

NCT05236426 | Unknown

• 1 other identifier: UWMOlsztyn
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to determine the correlation of the results of cardiac index (CI) measurements performed with use of bioreactance technology with the results of measurements made with the use of transpulmonary thermodilution. Both methods will be evaluated in reference to measurements based on echocardiography.

Conditions

Hemodynamic Instability

Keywords

hemodynamic monitoring; cardiovascular monitoring; bioreactance; echocardiography; pulmonary thermodilution

Outcome Measures

Primary Outcomes (3)

• Cardiac Index value measured by the transpulmonary thermodilution technique

  The cardiac index is expressed with units : Liters/minute/meter2

  The results of three measurements will be documented within five minutes

• Cardiac Index value measured with use of bioreactance technology

  The cardiac index is expressed with units : Liters/minute/meter2

  The results of ten measurements at intervals of 30 seconds will be documented within five minutes

• Cardiac index value determined with use an ultrasound technique (echocardiography)

  The cardiac index is expressed with units : Liters/minute/meter2

  The results of three measurements will be documented within five minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for intracranial pathology

You may qualify if:

• critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology

You may not qualify if:

• Age under 18
• Presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography)
• Presence of aortic / mitral valve pathology
• Presence of an implanted pacemaker

Sponsors & Collaborators

• University of Warmia and Mazury in Olsztyn: lead

Related Publications (10)

• Geerts BF, Aarts LP, Jansen JR. Methods in pharmacology: measurement of cardiac output. Br J Clin Pharmacol. 2011 Mar;71(3):316-30. doi: 10.1111/j.1365-2125.2010.03798.x.

  PMID: 21284692 BACKGROUND

• Demiselle J, Mercat A, Asfar P. Is there still a place for the Swan-Ganz catheter? Yes. Intensive Care Med. 2018 Jun;44(6):954-956. doi: 10.1007/s00134-018-5158-0. Epub 2018 May 23. No abstract available.

  PMID: 29796915 BACKGROUND

• Kobe J, Mishra N, Arya VK, Al-Moustadi W, Nates W, Kumar B. Cardiac output monitoring: Technology and choice. Ann Card Anaesth. 2019 Jan-Mar;22(1):6-17. doi: 10.4103/aca.ACA_41_18.

  PMID: 30648673 BACKGROUND

• Keren H, Burkhoff D, Squara P. Evaluation of a noninvasive continuous cardiac output monitoring system based on thoracic bioreactance. Am J Physiol Heart Circ Physiol. 2007 Jul;293(1):H583-9. doi: 10.1152/ajpheart.00195.2007. Epub 2007 Mar 23.

  PMID: 17384132 BACKGROUND

• Squara P, Denjean D, Estagnasie P, Brusset A, Dib JC, Dubois C. Noninvasive cardiac output monitoring (NICOM): a clinical validation. Intensive Care Med. 2007 Jul;33(7):1191-1194. doi: 10.1007/s00134-007-0640-0. Epub 2007 Apr 26.

  PMID: 17458538 BACKGROUND

• Raval NY, Squara P, Cleman M, Yalamanchili K, Winklmaier M, Burkhoff D. Multicenter evaluation of noninvasive cardiac output measurement by bioreactance technique. J Clin Monit Comput. 2008 Apr;22(2):113-9. doi: 10.1007/s10877-008-9112-5. Epub 2008 Mar 14.

  PMID: 18340540 BACKGROUND

• Porter TR, Shillcutt SK, Adams MS, Desjardins G, Glas KE, Olson JJ, Troughton RW. Guidelines for the use of echocardiography as a monitor for therapeutic intervention in adults: a report from the American Society of Echocardiography. J Am Soc Echocardiogr. 2015 Jan;28(1):40-56. doi: 10.1016/j.echo.2014.09.009. No abstract available.

  PMID: 25559474 BACKGROUND

• Malik SB, Chen N, Parker RA 3rd, Hsu JY. Transthoracic Echocardiography: Pitfalls and Limitations as Delineated at Cardiac CT and MR Imaging. Radiographics. 2017 Mar-Apr;37(2):383-406. doi: 10.1148/rg.2017160105. Epub 2017 Feb 17.

  PMID: 28212053 BACKGROUND

• Ling HZ, Gallardo-Arozena M, Company-Calabuig AM, Nicolaides KH, Kametas NA. Clinical validation of bioreactance for the measurement of cardiac output in pregnancy. Anaesthesia. 2020 Oct;75(10):1307-1313. doi: 10.1111/anae.15110. Epub 2020 May 29.

  PMID: 32469423 BACKGROUND

• Lamia B, Kim HK, Severyn DA, Pinsky MR. Cross-comparisons of trending accuracies of continuous cardiac-output measurements: pulse contour analysis, bioreactance, and pulmonary-artery catheter. J Clin Monit Comput. 2018 Feb;32(1):33-43. doi: 10.1007/s10877-017-9983-4. Epub 2017 Feb 10.

  PMID: 28188408 BACKGROUND

Central Study Contacts

Jan Adamski, MD,PhD

CONTACT

+48600700315; janski01@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 11, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share