Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance

NCT07020637 | Recruiting FDA Device

• 1 other identifier: UNLV-2024-124
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation Between Stroke Volume Measurements by Echocardiography and Bioreactance Monitoring

  Pearson 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.

  Within 1 hour of enrollment

Study Arms (1)

Shock Patients

This cohort includes adult patients presenting with clinical signs of shock in the intensive care unit. Each participant will undergo stroke volume measurement using both transthoracic echocardiography and bioreactance-based monitoring (Cheetah NICOM) before and after passive leg raising. No therapeutic intervention will be performed as part of the study.

Device: Cheetah NICOM

Interventions

Cheetah NICOM DEVICE

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.

Shock Patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the intensive care unit (ICU) with clinical signs of shock, including hypotension and/or evidence of end-organ hypoperfusion, who are able to provide informed consent or have a legally authorized representative available.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

University Medical Center Southern Nevada

Las Vegas, Nevada, 89102, United States

RECRUITING

MeSH Terms

Conditions

Shock; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Mutsumi J Kioka, Medical Doctor

  UNLV

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mutsumi J Kioka, Medical Doctor

CONTACT

7026712345; mutsumi.kioka@unlv.edu

Office of Research Integrity Human Subjects UNLV

CONTACT

7028952794; IRB@unlv.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: October 19, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)