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Hemodynamic InstabilityNCT05236426

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

An observational study of Hemodynamic Instability, run by University of Warmia and Mazury in Olsztyn.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hemodynamic Instability
How many people
50 participants
Where
No sites listed yet
Study dates
Feb 2022to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Jan Adamski, MD,PhD contact

+48600700315

janski01@hotmail.com

About this study

Official title: Comparison of Cardiac Index (CI) Measurements Performed With Use of the Bioreactance Technology and Transpulmonary Thermodilution in Reference to Measurements Based on Echocardiography.

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.

Read the detailed description

After approval of the study design by the institutional ethics committee, 50 critically ill adult patients (requiring haemodynamic monitoring and mechanical ventilation) treated in the ICU for a intracranial pathology will be enrolled in the study.

Exclusions: Age under 18, presence of pleural effusion or pericardium (confirmed by chest X-ray and / or ultrasound / echocardiography), presence of aortic / mitral valve disease, presence of an implanted pacemaker CI measurements will be performed simultaneously for 5 minutes. The CI value measured by the transpulmonary thermodilution technique will be obtained with the PiCCO system (Pulsiocat PV8115; Pulsion Medical Systems, Feldkirchen, Germany). Measurements will be made three times within 5 minutes. For statistical purposes, the value of the arithmetic mean of the obtained results will be used.

The CI value as measured by the bioreactance method will be determined using the monitor: Starling Fluid Management System (Baxter International Inc, USA). This monitor uses bioreactance technology to determine hemodynamic parameters and bioimpedance technology to measure thoracic fluid content (TFC). The test data will be recorded with two pairs of electrodes placed on the chest according to the manufacturer's instructions. Measurements documented at 30-second intervals will concern 10 measurement cycles. The average of the obtained results will be subjected to statistical analysis.

Echocardiographic examination of the heart to determine the value of CI will be performed by one (always the same) qualified (certified in echocardiographic examinations) clinician.

Echocardiographic measurements will begin with determining the diameter of the left ventricular outflow tract (left ventricular outflow tract cross-sectional area, LVOT-CSA). Then, three subvalvular velocity time integral (LVOT-VTI) measurements will be made over the course of 5 minutes. This measurement will be performed in the apical five-chamber projection.

The stroke volume (SV) value will be calculated as: SV = LVOT-CSA x LVOT-VTI. The CI value will be calculated using the formula: CI = SV x heart rate (HR) / body surface area (BSA). The CI value archived for further statistical analysis will be the average of three measurements performed within 5 minutes.

Other variables that will be documented simultaneously with CI measurements: patient gender and weight, use of vasospastic / inotropic drugs (dose mcg / kg / min), positive end expiratory pressure (PEEP), presence of pulmonary hypertension.

Keywords
hemodynamic monitoring, cardiovascular monitoring, bioreactance, echocardiography, pulmonary thermodilution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac Index value measured by the transpulmonary thermodilution technique

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

    Measured: The results of three measurements will be documented within five minutes

  2. Cardiac Index value measured with use of bioreactance technology

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

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

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

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

    Measured: The results of three measurements will be documented within five minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study startFeb 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236426
Sponsor's protocol ID
UWMOlsztyn
Status last verified
Feb 2022
First submitted
31 Jan 2022
Last updated
11 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available

Publications

  • 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.

    PubMed 21284692

  • 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.

    PubMed 29796915

  • 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.

    PubMed 30648673

  • 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.

    PubMed 17384132

  • 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.

    PubMed 17458538

  • 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.

    PubMed 18340540

  • 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.

    PubMed 25559474

  • 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.

    PubMed 28212053

  • 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.

    PubMed 32469423

  • 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.

    PubMed 28188408

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic Instability, run by University of Warmia and Mazury in Olsztyn.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jan Adamski, MD,PhD (+48600700315, janski01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Index value measured by the transpulmonary thermodilution technique (time frame: The results of three measurements will be documented within five minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236426, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.

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