ShockNCT07020637
Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance
An observational study of Shock and Critical Illness, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shock, Critical Illness
- What is being tested?
- Cheetah NICOM
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2024to 30 Apr 2026
- How long will I take part?
- 1 Day
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Center Southern Nevada
Las Vegas, Nevada, 89102
About this study
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.
Read the 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
- Being tested
- Cheetah NICOM
- Keywords
- Cheeta NICOM, Bioreactance, Transthoracic Echocardiography, Passive Leg Raising, Stroke Volume, Shock Assssment, Noninvasive Cardiac Output Monitoring
- Medical subject headings
- Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cheetah NICOMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cheetah NICOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 hour of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start19 Oct 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mutsumi J Kioka, Medical Doctor, Principal investigator, UNLV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020637
- Sponsor's protocol ID
- UNLV-2024-124
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of this single-center observational study. No long-term data storage or external data-sharing infrastructure has been established for this project.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Stroke Volume in Shock Using Echocardiography Versus Bioreactive Impedance
- ClinicalTrials.gov ID
- NCT07020637
- Acronym / sponsor ID
- UNLV-2024-124
- Conditions
- Shock, Critical Illness
- Keywords
- Cheeta NICOM, Bioreactance, Transthoracic Echocardiography, Passive Leg Raising, Stroke Volume, Shock Assssment, Noninvasive Cardiac Output Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock Patients | – | Device: Cheetah NICOMThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cheetah NICOMBioreactance-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. | Device | Shock Patients |
Primary outcome
Correlation Between Stroke Volume Measurements by Echocardiography and Bioreactance Monitoring
Time frame: Within 1 hour of enrollment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and the limited scope of this single-center observational study. No long-term data storage or external data-sharing infrastructure has been established for this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mutsumi J Kioka, Medical Doctor principal investigator
UNLV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Critical Illness, run by University of Nevada, Las Vegas at 1 site in United States.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Stroke Volume Measurements by Echocardiography and Bioreactance Monitoring (time frame: Within 1 hour of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.