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

58 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Perioperative Monitoring with Vitalstream for Low Cardiac Output is an effective treatment?

The available research shows that the Vitalstream device allows for continuous monitoring of cardiac output using a noninvasive finger cuff, which is beneficial for patients undergoing cardiac surgery. This method is compared to traditional thermodilution techniques, suggesting it could be a more convenient and less invasive option. However, the research also indicates that while there are potential benefits, the adoption of such monitoring technologies is still debated, and more studies are needed to confirm its effectiveness compared to standard monitoring strategies. ^{1 2 3 4 5}

What safety data exists for Vitalstream in monitoring low cardiac output?

The Vitalstream device, a noninvasive continuous physiological monitor, has been evaluated for its performance in cardiac output monitoring during cardiac surgery. However, the provided research does not specifically address safety data for Vitalstream. The studies focus on the device's functionality and comparison with other monitoring methods, but do not provide detailed safety outcomes or adverse event data related to its use. ^{1 6 7 8 9}

Is the treatment Vitalstream a promising treatment?

Yes, Vitalstream is a promising treatment because it offers continuous and non-invasive monitoring of cardiac output, which is important for managing heart function during surgery. It uses a simple finger cuff and communicates data wirelessly, making it easy to use and less invasive than traditional methods. ^{1 3 10 11 12}

Research Team

Ashish K Khanna, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Shedding light on perioperative hemodynamic monitoring. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using cardiac output monitoring to guide perioperative haemodynamic therapy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Cardiac output monitoring: basic science and clinical application. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

All this monitoring…what's necessary, what's not? [2015]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

The wolf is crying in the operating room: patient monitor and anesthesia workstation alarming patterns during cardiac surgery. [2010]

8. India 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. [2018]

9. Canada 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

New developments in perioperative cardiovascular monitoring. [2007]

11. England 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. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

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