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Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance

Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07020637
Enrollment
100
Registered
2025-06-13
Start date
2024-10-19
Completion date
2026-09-01
Last updated
2025-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock, Critical Illness

Keywords

Cheeta NICOM, Bioreactance, Transthoracic Echocardiography, Passive Leg Raising, Stroke Volume, Shock Assssment, Noninvasive Cardiac Output Monitoring

Brief summary

This study aims to evaluate the correlation between stroke volume measurements obtained by transthoracic echocardiography and bioreactance-based noninvasive cardiac output monitoring. The primary objective is to assess the level of agreement between these two modalities in critically ill patients.

Detailed description

In this prospective observational study, patients presenting with clinical signs of shock will be enrolled after obtaining informed consent. Stroke volume (SV) will be measured using both transthoracic echocardiography and bioreactance-based noninvasive cardiac output monitoring (Cheetah NICOM). SV will be recorded before and after passive leg raising (PLR) to evaluate the correlation between the two methods in terms of absolute values and directional changes (increase or decrease). No therapeutic intervention will be performed as part of the study; all clinical decisions will remain under the discretion of the treating medical team.

Interventions

Bioreactance-based noninvasive cardiac output monitoring device used to measure stroke volume before and after passive leg raising. Used solely for observational measurement. No therapeutic intervention is performed.

Sponsors

University of Nevada, Las Vegas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Clinical diagnosis of shock as determined by the treating ICU physician (e.g., hypotension requiring vasopressors or evidence of end-organ hypoperfusion) * Able to obtain informed consent from the patient or a legally authorized representative * Enrollment within 24 hours of ICU admission

Exclusion criteria

* Pregnancy * Known severe aortic valve disease or dynamic left ventricular outflow tract obstruction * Morbid obesity (BMI \> 40) that precludes accurate echocardiographic imaging Presence of cardiac arrhythmias (e.g., atrial fibrillation with rapid ventricular response) affecting stroke volume measurements * Implanted cardiac assist devices (e.g., LVAD, pacemaker dependency) * Imminent death or decision for comfort care only

Design outcomes

Primary

MeasureTime frameDescription
Correlation Between Stroke Volume Measurements by Echocardiography and Bioreactance MonitoringWithin 1 hour of enrollmentPearson correlation coefficient between stroke volume measurements obtained using transthoracic echocardiography and those obtained using bioreactance-based monitoring (Cheetah NICOM) in response to passive leg raising.

Countries

United States

Contacts

Primary ContactMutsumi J Kioka, Medical Doctor
mutsumi.kioka@unlv.edu7026712345
Backup ContactOffice of Research Integrity Human Subjects UNLV
IRB@unlv.edu7028952794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026