Cardiac OutputNCT05779683
Caretaker in the Cardiovascular Intensive Care Unit (CVICU)
An observational study of Cardiac Output and Hemodynamic Monitoring, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Hemodynamic Monitoring
- What is being tested?
- Caretaker Device placement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 28 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p CABG, valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
Who may be able to join
- Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p Coronary artery bypass graft surgery (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)
- Pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure monitoring (standard of care)
Who cannot join
- Patients without an appropriately positioned or functioning PA 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
Official title: Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU
To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker 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. This device also does not project energy into the subject.
Read the detailed description
Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker 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. This device also does not project energy into the subject.
- Conditions
- Cardiac Output, Hemodynamic Monitoring
- Being tested
- Caretaker Device placement
- Keywords
- cardiopulmonary bypass, Blood Pressure (BP) monitoring, Pulmonary Artery (PA) catheters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caretaker Device placementDevice
placement of the device on the postoperative cardiac surgery patient that has a pulmonary artery catheter for comparison readings
| Study group | Role | What they receive |
|---|---|---|
| Caretaker device in CVICU patient | device placed on the subject after arrival to the cardiac intensive care unit postoperatively Receives: Device: Caretaker Device placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of hemodynamic readings between the Caretaker and the PAC
To assess the agreement of the Caretaker monitor CO with the thermodilution method using the swan-ganz or pulmonary artery (PAC) catheter in critically ill cardiac surgery post-op ICU patients.
Measured: 24 hours
Number of Periods of Carbon monoxide (CO) Instability
The incidence of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care
Measured: 24 hours
Time Spent in Periods of CO Instability
The time spent during periods of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Nov 2021
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT05779683
- Sponsor's protocol ID
- IRB00074289
- Status last verified
- Jun 2022
- First submitted
- 9 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Of Cardiac Output Using Pulse Decomposition Analysis In Post-Cardiac Surgery Patients In The ICU
- ClinicalTrials.gov ID
- NCT05779683
- Acronym / sponsor ID
- IRB00074289
- Conditions
- Cardiac Output, Hemodynamic Monitoring
- Keywords
- cardiopulmonary bypass, Blood Pressure (BP) monitoring, Pulmonary Artery (PA) catheters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 22 Mar 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.
To monitor the cardiac post-op patient population with both the pulmonary artery catheter (PAC) and the Caretaker monitor, which will seek to validate the Caretaker monitor against continuous CO via the PAC. Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker 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. This device also does not project energy into the subject.
Detailed description
Up to a third of post-operative cardiac surgery patients develop cardiac arrhythmias such as atrial flutter and atrial fibrillation. Secondary analysis will be performed on the collected data to assess the Caretaker monitor's agreement with the PAC during periods of arrhythmia. Successful completion this study will provide clinical validation of the Caretaker monitor in one of the most hemodynamically challenging patient populations (post-cardiac surgery patients in the ICU), including during arrhythmias. The Caretaker 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. This device also does not project energy into the subject.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caretaker device in CVICU patient | – | Device: Caretaker Device placementdevice placed on the subject after arrival to the cardiac intensive care unit postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p CABG, valve, heart transplant, major aortic \& other vascular surgery, and a combination of CABG and valve procedures)
Key inclusion criteria (3 listed)
- Adult post-cardiac surgery needing cardiopulmonary bypass and use of the PAC as standard of care, (s/p Coronary artery bypass graft surgery (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)
- Pulmonary artery catheter (continuous or intermittent thermodilution cardiac output) and an arterial catheter for Blood Pressure monitoring (standard of care)
Key exclusion criteria (2 listed)
- Patients without an appropriately positioned or functioning PA 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 |
|---|---|---|
| Caretaker Device placementplacement of the device on the postoperative cardiac surgery patient that has a pulmonary artery catheter for comparison readings | Device | Caretaker device in CVICU patient |
Primary outcome
Comparison of hemodynamic readings between the Caretaker and the PAC
Time frame: 24 hours
To assess the agreement of the Caretaker monitor CO with the thermodilution method using the swan-ganz or pulmonary artery (PAC) catheter in critically ill cardiac surgery post-op ICU patients.
Number of Periods of Carbon monoxide (CO) Instability
Time frame: 24 hours
The incidence of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care
Time Spent in Periods of CO Instability
Time frame: 24 hours
The time spent during periods of CO instability after removal of PAC. Comparison of hemodynamic readings after removal of the PAC between the Caretaker and vital signs obtained as standard of care.
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 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Output
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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?
An observational study of Cardiac Output and Hemodynamic Monitoring, 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 3 inclusion and 2 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 22 Mar 2023. 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?
Comparison of hemodynamic readings between the Caretaker and the PAC (time frame: 24 hours). The study lists 3 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 22 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.