Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance

NCT ID: NCT07020637

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-19
• Study Completion Date: 2026-09-01

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.

Conditions

Shock; Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cheetah NICOM

Intervention Type: 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.

Interventions

Cheetah NICOM

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nevada, Las Vegas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mutsumi J Kioka, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

UNLV

Locations

University Medical Center Southern Nevada

Las Vegas, Nevada, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mutsumi J Kioka, Medical Doctor

Role: CONTACT

mutsumi.kioka@unlv.edu

7026712345

Office of Research Integrity Human Subjects UNLV

Role: CONTACT

IRB@unlv.edu

7028952794

Facility Contacts

Mutsumi J Kioka, Medical Doctor

Role: primary

mutsumi.kioka@unlv.edu

7026712345

Other Identifiers

UNLV-2024-124

Identifier Type: -

Identifier Source: org_study_id