Perioperative Monitoring with Vitalstream for Low Cardiac Output

Overseen By Ashish K Khanna, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: LVAD support, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Vitalstream, which monitors heart health without needles or other invasive methods. Researchers aim to determine if Vitalstream can accurately measure heart function compared to the standard method of inserting a catheter (a thin tube) into the heart. The study seeks participants who have recently undergone heart surgery and are already using a catheter in the ICU as part of their normal care. This trial may suit those who have recently had major heart-related surgeries and are in the intensive care unit. As an unphased trial, it offers participants the chance to contribute to innovative heart health monitoring research.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the Vitalstream device is safe for monitoring cardiac output?

Research has shown that the Vitalstream device has been tested on many patients, including those undergoing high-risk surgeries. Studies have found that it provides accurate and reliable information. Importantly, it is noninvasive, meaning it doesn't use needles or require procedures inside the body, making it safer and more comfortable for patients. No serious side effects have been reported so far, suggesting that the device is well-tolerated and safe for monitoring heart and blood flow during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for low cardiac output involve medications or surgical interventions to support heart function. However, Vitalstream is unique because it introduces a non-invasive monitoring device that can continuously track a patient's vital signs from the preoperative phase through their stay in the Cardiac Intensive Care Unit (ICU). This continuous monitoring allows for real-time data collection and analysis, which can help clinicians make faster, more informed decisions. Researchers are excited because this could lead to better patient outcomes by allowing for more personalized and timely interventions.

What evidence suggests that the Vitalstream device is effective for monitoring low cardiac output?

Research has shown that the Vitalstream device, used by participants in this trial, effectively measures heart function without invasive procedures. In one study, researchers analyzed over 15,000 data points and found that Vitalstream's measurements were accurate within 35%, surpassing the usual 45% limit for noninvasive devices. This accuracy allows it to effectively track cardiac output (the amount of blood the heart pumps) and stroke volume (the amount of blood pumped with each heartbeat). The device is particularly useful for monitoring patients after heart surgery, as it provides continuous updates without the need for blood draws or other invasive methods. Overall, these findings suggest that Vitalstream is a promising tool for safely and accurately monitoring heart health in clinical settings. ^{1 3 5 6 7}

Who Is on the Research Team?

Ashish K Khanna, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 in the ICU after cardiac surgery who need a pulmonary artery catheter and arterial BP monitoring. It's not for patients with left ventricular assist devices or those without a properly placed or working pulmonary artery catheter post-surgery.

Inclusion Criteria

I had heart surgery requiring a heart-lung machine and a special heart monitoring catheter.

Exclusion Criteria

You are currently using a left ventricular assist device (LVAD) for heart support.

I don't have a working lung artery catheter after heart surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Monitoring

Device placed on the subject preoperatively in the holding room

Hours

1 visit (in-person)

Postoperative Monitoring

Continued monitoring in the Cardiac Intensive Care Unit (ICU) using the Vitalstream device

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitalstream

Trial Overview The study tests Vitalstream, a noninvasive monitor that measures heart rate, blood pressure, respiratory rate, stroke volume, and cardiac output against standard thermodilution methods used in intensive care.

How Is the Trial Designed?

Group I: Vitalstream Experimental Treatment 1 Intervention

Device placed on the subject preoperatively in the holding room and continued postoperatively into the Cardiac Intensive Care Unit (ICU).

Vitalstream is already approved in United States, Canada for the following indications:

Approved in United States as VitalStream for:

• Cardiac output monitoring
• Stroke volume monitoring
• Blood pressure monitoring

Approved in Canada as VitalStream for:

• Research use only

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a pilot study involving 226 surgical patients, continuous remote vital signs monitoring led to faster administration of antibiotics for sepsis, with an average time of 626 minutes compared to 1012.8 minutes for those with intermittent monitoring.

Patients using continuous monitoring experienced a shorter hospital stay (13.3 days vs. 14.6 days) and a lower 30-day readmission rate (11.4% vs. 20.9%), indicating potential benefits, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial. Downey, C., Randell, R., Brown, J., et al.[2021]

Cardiac output monitoring devices are used to guide perioperative hemodynamic therapy, but there is currently no strong evidence showing that one device is superior to others in improving surgical outcomes.

While previous studies suggested that goal-directed therapy (GDT) could enhance recovery after major surgery, recent larger trials have not consistently shown benefits, indicating that more research is needed to establish GDT as a standard of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using cardiac output monitoring to guide perioperative haemodynamic therapy. McGuinness, S., Parke, R.[2022]

Current standard perioperative monitoring methods, such as continuous electrocardiography and blood pressure monitoring, are primarily based on expert opinion and observational studies, and while they can identify life-threatening events, they do not provide direct insights into a patient's oxygen economy.

Emerging non-routine monitoring techniques, like venous saturation monitoring and near infrared spectroscopy, show promise in improving patient management during surgery by offering additional data on oxygen levels, but high-level evidence is still needed for widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All this monitoring…what's necessary, what's not? Tweddell, JS., Ghanayem, NS., Hoffman, GM.[2015]

The Vitalstream (VS) continuous physiological monitor demonstrated clinically acceptable agreement with thermodilution cardiac output measurements during cardiac surgery, with a percent error of 34.5 to 38%, which is below the acceptable threshold of 40%.

This noninvasive monitoring technology offers a promising alternative for continuous cardiac output measurement, potentially expanding access to effective fluid management tools in hospital settings that previously relied on traditional invasive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi. Gratz, I., Baruch, M., Awad, A., et al.[2023]

Perioperative monitoring with pulse oximetry significantly reduces the occurrence of hypoxaemia during surgery by allowing for timely detection and treatment of low oxygen levels, which can improve patient care.

However, despite its benefits in monitoring, pulse oximetry does not significantly decrease the overall number of postoperative complications, indicating that while it is a valuable tool, it may not directly improve all surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does perioperative pulse oximetry improve outcome? Seeking the best available evidence to answer the clinical question. Pedersen, T.[2019]

Recent advancements in perioperative cardiovascular monitoring include continuous and non-invasive blood pressure monitoring, which enhances patient safety during surgery.

New echocardiography techniques and improved methods for detecting myocardial infarction (MI) have significantly improved the ability to monitor heart function and ischemia, leading to better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in perioperative cardiovascular monitoring. Jain, U.[2007]

A review of 22 studies involving over 203,000 patients found that both continuous and intermittent vital signs monitoring can help identify patient deterioration early and improve the documentation of vital signs.

Despite some benefits in early detection, there was no significant reduction in ICU transfers or other serious adverse events, indicating that continuous vital signs monitoring may not be necessary as a routine practice in general wards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of continuous or intermittent vital signs monitoring in preventing adverse events on general wards: a systematic review and meta-analysis. Cardona-Morrell, M., Prgomet, M., Turner, RM., et al.[2018]

Cardiac output-guided hemodynamic management has been extensively studied and is believed to offer clinical and economic benefits for patients undergoing high-risk surgery, yet its adoption in clinical practice remains low.

To enhance the value of cardiac output monitoring in routine anesthesia management, there is a need for better patient selection, cost-effective monitoring solutions, and personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shedding light on perioperative hemodynamic monitoring. Michard, F., Futier, E., Saugel, B.[2021]

In a study of 25 patients undergoing elective cardiac surgery, a total of 8,975 alarms were recorded, with 80% of these alarms having no therapeutic consequences, highlighting the issue of alarm fatigue in clinical settings.

The study suggests that optimizing alarm settings and improving detection of non-critical alarms could enhance patient safety and ensure that critical alarms are not ignored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The wolf is crying in the operating room: patient monitor and anesthesia workstation alarming patterns during cardiac surgery. Schmid, F., Goepfert, MS., Kuhnt, D., et al.[2010]

A study involving 270 measurements during elective cardiac bypass surgery found that the HEARTSMART software provides an accurate estimate of cardiac index, which is crucial for monitoring heart function in critically ill patients.

The mean bias for cardiac index measurements was minimal, indicating that HEARTSMART can reliably assist in guiding treatment decisions during major surgery and in intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new, minimally invasive technique for measuring cardiac index: clinical comparison of continuous cardiac dynamic monitoring and pulmonary artery catheter methods. Berridge, JC., Warring-Davies, K., Bland, JM., et al.[2019]

Continuous haemodynamic monitoring, particularly of flow-based variables like stroke volume and cardiac output, is crucial in preventing hidden low blood flow (occult hypoperfusion) during surgery, which can reduce complications and improve patient outcomes.

Despite the benefits of both invasive and newer non-invasive monitoring technologies, there is a significant gap between the evidence from clinical trials and their actual use in everyday practice, highlighting the need for better integration of these tools in the operating room.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practice & research clinical anaesthesiology: Advances in haemodynamic monitoring for the perioperative patient: Perioperative cardiac output monitoring. Bein, B., Renner, J.[2020]

Cardiac output monitoring is crucial for managing patients with sepsis, trauma, and other critical illnesses, as it helps evaluate circulation effectively during treatment.

Various technologies exist for measuring cardiac output, each based on different physiological principles, highlighting the need for healthcare professionals to understand these principles for safe and effective clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac output monitoring: basic science and clinical application. Jhanji, S., Dawson, J., Pearse, RM.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05905536

Perioperative Monitoring of Cardiac Surgery Patients With ... The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using ...

2. withpower.com withpower.com/trial/phase-cardiac-output-low-5-2023-72850

Perioperative Monitoring with Vitalstream for Low Cardiac ... The purpose of this study is to validate cardiac output and stroke volume derived from Vitalstream against Gold Standard measurements obtained using ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02114-z

A new continuous noninvasive finger cuff device (Vitalstream ... A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi.

4. caretakermedical.net caretakermedical.net/blog/continuous-cardiac-output-measurements-post-cardiac-surgery-patients/

New Study Confirms the Accuracy of VitalStream's ... The study examined over 15,000 data points. VitalStream showed an absolute agreement of 35% which is comfortably under the 45% limit benchmark for noninvasive ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37231335/

A new continuous noninvasive finger cuff device ... A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05905536

Perioperative Monitoring of Cardiac Surgery Patients With ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. caretakermedical.net caretakermedical.net/operating-theater-patient-monitor/

Perioperative hemodynamic monitoring VitalStream has been validated through all-comer studies and proven to provide accurate and reliable data across high-risk surgical patient populations.