Cardiac Output, LowNCT05905536
Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
A study testing Vitalstream in people with Cardiac Output, Low and Stroke Volume, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM")… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low, Stroke Volume
- What is being tested?
- Vitalstream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 30 Jul 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult post-cardiac surgery needing cardiopulmonary bypass and use of the pulmonary artery catheter (PAC) as standard of care, (s/p coronary artery bypass graft (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
- patients (age > 18) admitted to the Intensive Care Unit (ICU) with a pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure (BP) monitoring (standard of care)
Who cannot join
- Patients without an appropriately positioned or functioning (PAC) pulmonary artery catheter admitted to the cardiac surgery ICU after surgery. Patients on left ventricular assist device (LVAD) support
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.
Read the detailed description
The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure [30-40 mmHg], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject.
- Conditions
- Cardiac Output, Low, Stroke Volume
- Being tested
- Vitalstream
- Keywords
- cardiac output, cardiac surgery, pulmonary artery catheter
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitalstreamDevice
The device will be placed on the subject and monitoring started in the holding room on the morning of surgery. Monitoring will continue postoperatively until the pulmonary artery catheter (PAC) is removed (Standard of Care) or discharged, or at study team discretion. At Intensive Care Unit (ICU) admittance and again 3 hours later a straight leg raise will be done to monitor for changes in hemodynamics.
| Study group | Role | What they receive |
|---|---|---|
| Vitalstream | Experimental | Device placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU). Receives: Device: Vitalstream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output values
Cardiac output values correlation of cardiac output between the PA catheter as assessed by the CCO and the VitalStream - the amount of blood pumped by the heart minute - Cardiac output is calculated by multiplying stroke volume with heart rate - Cardiac output in humans is generally 5-6 L/min in an at-rest to more than 35 L/min in elite athletes during exercise. HR is determined by signals from the sinoatrial node, which automatically depolarizes at an intrinsic rate of 60 to 100 times each minute - Low-output symptoms are caused by the inability of the heart to generate enough cardiac output. This leads to reduced blood flow to the brain and other vital organs
Measured: hour 24
Blood pressure values
correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line
Measured: hour 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Aug 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cardiac patient population through the major part of their continuum of care, with monitoring starting at the start of the subjects holding room pre-operative preparation and continuing through surgery to recovery in the Cardiovascular Intensive Care Unit (CVICU), where monitoring will continue until the pulmonary artery catheter (PAC) is removed
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashish Khanna, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905536
- Sponsor's protocol ID
- IRB00096075
- Status last verified
- Feb 2025
- First submitted
- 7 Jun 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Monitoring of Cardiac Surgery Patients With the Vitalstream Physiological Monitor
- ClinicalTrials.gov ID
- NCT05905536
- Acronym / sponsor ID
- IRB00096075
- Conditions
- Cardiac Output, Low, Stroke Volume
- Keywords
- cardiac output, cardiac surgery, pulmonary artery catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 15 Jun 2023 (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.
The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using thermodilution. The Vitalstream device is a continuous noninvasive physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia, further referred to as "CTM") provides heart rate, continuous noninvasive blood pressure (BP), respiratory rate, stroke volume and cardiac output.
Detailed description
The device is currently undergoing IEC 60601 Medical Safety Standards testing and has already passed all FDA-required emission and discharge testing. The Vitalstream tracks central aortic BP via pulse analysis, specifically Pulse Decomposition Analysis ("PDA"), of the peripheral pulse at a distal site, typically finger. The device uses a low pressure [30-40 mmHg], pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a custom-designed piezo-electric pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth. The Vitalstream monitor is most beneficial as it is non-invasive, is a minimal risk device, and for this protocol will not be utilized to make treatment decisions for the study subject.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cardiac patient population through the major part of their continuum of care, with monitoring starting at the start of the subjects holding room pre-operative preparation and continuing through surgery to recovery in the Cardiovascular Intensive Care Unit (CVICU), where monitoring will continue until the pulmonary artery catheter (PAC) is removed
| Arm | Type | Receives |
|---|---|---|
| Vitalstream | Experimental | Device: VitalstreamDevice placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult post-cardiac surgery needing cardiopulmonary bypass and use of the pulmonary artery catheter (PAC) as standard of care, (s/p coronary artery bypass graft (CABG), valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
- patients (age > 18) admitted to the Intensive Care Unit (ICU) with a pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure (BP) monitoring (standard of care)
Key exclusion criteria (1 listed)
- Patients without an appropriately positioned or functioning (PAC) pulmonary artery catheter admitted to the cardiac surgery ICU after surgery. Patients on left ventricular assist device (LVAD) support
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 |
|---|---|---|
| VitalstreamThe device will be placed on the subject and monitoring started in the holding room on the morning of surgery. Monitoring will continue postoperatively until the pulmonary artery catheter (PAC) is removed (Standard of Care) or discharged, or at study team discretion. At Intensive Care Unit (ICU) admittance and again 3 hours later a straight leg raise will be done to monitor for changes in hemodynamics. | Device | Vitalstream |
Primary outcome
Cardiac output values
Time frame: hour 24
Cardiac output values correlation of cardiac output between the PA catheter as assessed by the CCO and the VitalStream - the amount of blood pumped by the heart minute - Cardiac output is calculated by multiplying stroke volume with heart rate - Cardiac output in humans is generally 5-6 L/min in an at-rest to more than 35 L/min in elite athletes during exercise. HR is determined by signals from the sinoatrial node, which automatically depolarizes at an intrinsic rate of 60 to 100 times each minute - Low-output symptoms are caused by the inability of the heart to generate enough cardiac output. This leads to reduced blood flow to the brain and other vital organs
Blood pressure values
Time frame: hour 24
correlation of blood pressure continuously being monitored by the Vitalstream and the subjects indwelling arterial line
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Ashish Khanna, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitalstream in people with Cardiac Output, Low and Stroke Volume, run by Wake Forest University Health Sciences 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 2 inclusion and 1 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 12 Aug 2025. 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?
Cardiac output values (time frame: hour 24). The study lists 2 primary outcomes in all. 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 12 Aug 2025.