Perioperative Monitoring with Vitalstream for Low Cardiac Output
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Wake Forest University Health Sciences
No Placebo Group
Approved in 2 Jurisdictions
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.12345
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.16789
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.13101112
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 am over 18, in the ICU, and have catheters for heart and BP monitoring.
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.
Treatment Details
Interventions
- Vitalstream (Physiological Monitor)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: VitalstreamExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Atrium Health Wake Forest BaptistWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
References
A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi. [2023]The new noninvasive Vitalstream (VS) continuous physiological monitor (Caretaker Medical LLC, Charlottesville, Virginia), allows continuous cardiac output by a low pump-inflated, finger cuff that pneumatically couples arterial pulsations via a pressure line to a pressure sensor for detection and analysis. Physiological data are communicated wirelessly to a tablet-based user interface via Bluetooth or Wi-Fi. We evaluated its performance against thermodilution cardiac output in patients undergoing cardiac surgery.
Shedding light on perioperative hemodynamic monitoring. [2021]Given the number of clinical studies and meta-analyses investigating the impact of cardiac output-guided hemodynamic management on the postoperative outcome of patients undergoing high-risk surgery, clinicians should already have a fair idea of the clinical and economic benefits. However, this is still a matter of debate, there are still large outcome studies going on, and surveys and audits have shown that clinical adoption remains low. Rational patient selection, more affordable monitoring solutions, and the personalization of therapeutic strategies are desirable to ensure that cardiac output monitoring adds value and becomes part of the routine anesthesia management of high-risk surgical patients.
Using cardiac output monitoring to guide perioperative haemodynamic therapy. [2022]The aim of this study was to review recent advances and evidence for the use of cardiac output monitors to guide perioperative haemodynamic therapy.
Cardiac output monitoring: basic science and clinical application. [2021]Derangements in the circulation are a common feature of sepsis, trauma, major surgery and other critical illnesses. Detailed evaluation of the circulation is therefore an essential aspect of the clinical management of such patients. The use of cardiac output monitoring technology is an increasingly important aspect of evaluating patients in the operating theatre, critical care unit and elsewhere. There are now a number of different technologies available for this purpose, which use a diverse range of physiological principles. A detailed understanding of the physiological principles applied by such technology is essential for safe and effective use in clinical practice. The aim of this article is to describe the physiological principles used to measure cardiac output and their application in various monitors in common clinical use.
All this monitoring…what's necessary, what's not? [2015]The goal of perioperative monitoring is to aid the clinician in optimizing care to achieve the best possible survival with the lowest possible morbidity. Ideally, we would like to have monitoring that can rapidly and accurately identify perturbations in circulatory well-being that would permit timely intervention and allow for restoration before the patient is damaged. The evidence to support the use of our standard monitoring strategies (continuous electrocardiography, blood pressure, central venous pressure, oxygen saturation and capnography) is based on expert opinion, case series, or at best observational studies. While these monitoring parameters will identify life-threatening events, they provide no direct information concerning the oxygen economy of the patient. Nevertheless, they are mandated by professional societies representing specialists in cardiac disease, critical care, and anesthesiology. Additional non-routine monitoring strategies that provide data concerning the body's oxygen economy, such as venous saturation monitoring and near infrared spectroscopy, have shown promise in prospective observational studies in managing these complex groups of patients. Ideally, high-level evidence would be required before adopting these newer strategies, but in the absence of new funding sources and the challenges of the wide variation in practice patterns between centers, this seems unlikely. The evidence supporting the current standard perioperative monitoring strategies will be reviewed. In addition, evidence supporting non-routine monitoring strategies will be reviewed and their potential for added benefit assessed.
Does perioperative pulse oximetry improve outcome? Seeking the best available evidence to answer the clinical question. [2019]The aim of this chapter is to clarify the effect of perioperative monitoring with pulse oximetry and to identify the adverse outcomes that might be prevented or improved by its use. Trials were identified by computerized searches of The Cochrane Library, MEDLINE and EMBASE, and by checking the reference lists of trials and review articles. All controlled trials that randomized patients to either pulse oximetry or no pulse oximetry during the perioperative period, including the operating and recovery room, were included in the search. Pulse oximetry monitoring was shown to substantially reduce the extent of perioperative hypoxaemia, enabling the detection and treatment of hypoxaemia and related respiratory events, and promoting several changes in patient care. The implementation of perioperative pulse oximetry monitoring does not significantly reduce the number of postoperative complications, but the question remains whether pulse oximetry can improve outcomes in other situations. Pulse oximetry has been adopted all over the world in clinical practice as a tool that guides anaesthesiologists in the daily management of patients: in teaching situations, in emergencies, and especially in the care of children. Given the relatively small number of patients studied in these trials and the rare events being sought, the studies of perioperative monitoring with pulse oximetry were not able to show an improvement in the outcomes studied.
The wolf is crying in the operating room: patient monitor and anesthesia workstation alarming patterns during cardiac surgery. [2010]Vital sign monitors and ventilator/anesthesia workstations are equipped with multiple alarms to improve patient safety. A high number of false alarms can lead to a "crying wolf" phenomenon with consecutively ignored critical situations. Systematic data on alarm patterns and density in the perioperative phase are missing. Our objective of this study was to characterize the patterns of alarming of a commercially available patient monitor and a ventilator/anesthesia workstation during elective cardiac surgery.
Effectiveness of continuous or intermittent vital signs monitoring in preventing adverse events on general wards: a systematic review and meta-analysis. [2018]Vital signs monitoring is an old hospital practice for patient safety but evaluation of its effectiveness is not widespread. We aimed to identify strategies to improve intermittent or continuous vital signs monitoring in general wards; and their effectiveness in preventing adverse events on general hospital wards.
Continuous Versus Intermittent Vital Signs Monitoring Using a Wearable, Wireless Patch in Patients Admitted to Surgical Wards: Pilot Cluster Randomized Controlled Trial. [2021]Vital signs monitoring is a universal tool for the detection of postoperative complications; however, unwell patients can be missed between traditional observation rounds. New remote monitoring technologies promise to convey the benefits of continuous monitoring to patients in general wards.
New developments in perioperative cardiovascular monitoring. [2007]Substantial technological progress has been made recently in the area of perioperative cardiovascular monitoring. Specialized monitoring may be performed for problems identified by preoperative evaluation. New technologies have been developed for monitoring the blood pressure continuously and non-invasively. Electrocardiographic monitoring of perioperative ischemia has been characterized. Newer techniques in echocardiography such as the use of contrast, and tissue characterization allowed improved monitoring of ischemia as well as ventricular function. Continuous monitoring of cardiac output can be performed by impedance cardiography and Doppler ultrasound and by continuous thermodilution. Improved rules for the differentiation of ventricular from supraventricular tachycardia have been developed. Detection of MI has been facilitated by new scintigraphic and enzymatic techniques. In critically ill patients, multi-system monitoring may be required to adequately assess the cardiovascular system.
A new, minimally invasive technique for measuring cardiac index: clinical comparison of continuous cardiac dynamic monitoring and pulmonary artery catheter methods. [2019]To assess the utility of a relatively simple bedside method of estimating cardiac index during major surgery or in the intensive care unit, we conducted a prospective study in patients undergoing elective cardiac bypass surgery where a pulmonary artery catheter was inserted as part of routine monitoring. The cardiac index was estimated using standard techniques and compared with estimates from continuous cardiac dynamic monitoring using HEARTSMART software. Two hundred and seventy sets of measurements were suitable for comparison. The mean bias (95% limits of agreement), for the pre-bypass cardiac index was -0.09 (-1.26 to 1.08) l x min(-1) x m(-2), and post-bypass was 0.12 l x min(-1) x m(-2) (-1.32 to 1.56). These results suggest that continuous cardiac dynamic monitoring using HEARTSMART is sufficiently accurate for assessment of haemodynamic variables in critically ill patients, facilitating goal-directed therapies.
Best practice & research clinical anaesthesiology: Advances in haemodynamic monitoring for the perioperative patient: Perioperative cardiac output monitoring. [2020]Less invasive or even completely non-invasive haemodynamic monitoring technologies have evolved during the last decades. Even established, invasive devices such as the pulmonary artery catheter and transpulmonary thermodilution have still an evidence-based place in the perioperative setting, albeit only in special patient populations. Accumulating evidence suggests to use continuous haemodynamic monitoring, especially flow-based variables such as stroke volume or cardiac output to prevent occult hypoperfusion and, consequently, decrease morbidity and mortality perioperatively. However, there is still a substantial gap between evidence provided by randomised trials and the implementation of haemodynamic monitoring in daily clinical routine. Given the fact that perioperative morbidity and mortality are higher than anticipated and anaesthesiologists are in charge to deal with this problem, the recent advances in minimally invasive and non-invasive monitoring technologies may facilitate more widespread use in the operating theatre, as in addition to costs, the degree of invasiveness of any monitoring tool determines the frequency of its application, at least perioperatively. This review covers the currently available invasive, non-invasive and minimally invasive techniques and devices and addresses their indications and limitations.