Clinical trial NCT07020637: Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance
Official title: Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shock
Critical Illness
Keywords: Cheeta NICOM
Bioreactance
Transthoracic Echocardiography
Passive Leg Raising
Stroke Volume
Shock Assssment
Noninvasive Cardiac Output Monitoring
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Correlation Between Stroke Volume Measurements by Echocardiography and Bioreactance Monitoring
timeFrame: Within 1 hour of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University Medical Center Southern Nevada
state: Nevada
Study officials:
affiliation: UNLV
name: Mutsumi J Kioka, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: