New Study Finds That Masimo SedLine® Patient State Index (PSi) Has the Potential to Improve Brain Monitoring for Patients Sedated with Dexmedetomidine
Norso Partner Company, Masimo have announced the findings of a study published in Frontiers in Neuroscience in which Dr. Lichy Han and colleagues at Stanford University evaluated the ability of Masimo SedLine® brain function monitoring to assess the sedation levels of patients undergoing drug-induced sleep endoscopy (DISE) with dexmedetomidine – a sedative with numerous advantages. The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and ha[s] potential to improve the monitoring of dexmedetomidine sedation.”1
The researchers noted that while anesthesia induced with dexmedetomidine may more closely resemble natural sleep compared to other sedatives, which makes it particularly appropriate in procedures like DISE, its effects on the brain are inconsistent, which has limited its usage. Better sedation assessment – an improved understanding of its impact and corresponding EEG changes – could help support more widespread adoption of the drug. The researchers accordingly sought to compare and evaluate several methods of assessing sedation in such a scenario. Regarding the choice of EEG markers, they noted that “Previous EEG markers, such as the bispectral index, have been unable to determine differences elicited with dexmedetomidine (Kaskinoro et al., 2011), thus motivating the discovery of novel EEG markers associated with changes in brain state seen with dexmedetomidine sedation.”
They enrolled 51 patients undergoing DISE, for the diagnosis and possible treatment of obstructive sleep apnea, who were sedated with dexmedetomidine and continuously monitored using Masimo SedLine. The concentration of the drug in their bloodstream was determined using a pharmacokinetic model. The concentration levels over time were recorded alongside the values derived from four methods of assessment, two metrics and two analyses: 1) the Richmond Agitation-Sedation Scale (RASS), 2) the SedLine Patient State Index (PSi), 3) spectral edge frequency (SEF95), the frequency below which 95% of total EEG power was contained, and 4) the correlation dimension (CD), a type of fractal dimension used to assess the complexity of a system. To evaluate the efficacy of these methods, the researchers compared them both against dexmedetomidine concentration and against each other.
Comparing the assessment methods to dexmedetomidine concentration, the researchers observed that RASS scores decreased with increasing dexmedetomidine concentration but noted that, “Overall, the RASS score was least able to capture the brain state changes seen with dexmedetomidine, suggesting other metrics for titrating dexmedetomidine sedation may be of greater value.” They found that PSi, SEF95, and CD all decreased statistically significantly with increasing dexmedetomidine concentration (p < 0.001, p = 0.006, and p < 0.001, respectively), “a clear dose-dependent decrease with an inflection point.”
Comparing the methods to each other, they found that PSi, SEF95, and CD all decreased statistically significantly with decreasing RASS score (p < 0.001, p < 0.001, and p = 0.02, respectively), most notably at deeper levels of sedation, suggesting that this is when they may be most beneficial. CD and SEF95 were statistically significantly correlated (p < 0.001, r = 0.515), but there was a subset of points that exhibited high SEF95 but low CD. PSi was most strongly correlated with SEF95 (p < 0.001, r = 0.631).
The researchers concluded, “Complex EEG metrics such as PSi and CD, as compared to RASS score and SEF95, better captured changes in brain state from dexmedetomidine and have potential to improve the monitoring of dexmedetomidine sedation.” In their discussion, they noted that, “CD excelled at reflecting changes seen with rising dexmedetomidine concentration but appeared to exhibit a ceiling effect, whereas PSi had the most significant relationship with the RASS score. Both metrics were able to capture brain state changes corresponding to increased dexmedetomidine dose, showed decreased sensitivity to observer variability and artifact, and corresponded to currently used infusion dosages in pharmacokinetic simulations.”
Study lead authors Lichy Han, MD, PhD and David Drover, MD, Perioperative and Pain Medicine at Stanford University, commented, “This study provides one more step in the journey to understanding SedLine processed EEG parameters that can guide sedation levels. In this case, dexmedetomidine, a widely used sedative, which has not been fully characterized by processed EEG, was titrated using standard indices PSi, SEF95, as well as fractal dimension (CD) commonly applied to time series data like EEG. In contrast to BIS, SedLine parameters (particularly PSi) were able to characterize processed EEG changes that correlated with dexmedetomidine sedation level and concentration, and these parameters correlated better than the subjective measure RASS (the most widely used clinical measure of sedation depth). This work helps clinicians use SedLine as an objective measure reflecting how the brain is responding to this important sedative, dexmedetomidine.”
Further Details of the Study can be found here – https://www.masimo.com/company/news/news-media/?utm_source=linkedin&utm_medium=social&utm_term=&utm_content=&utm_campaign=FY23_SedlinePR#New_Study_Finds_That_Masimo_SedLine_Patient_State_Index_(PSi)_Has_the_Potential_to_Improve_Brain_Monitoring_for_Patients_Sedated_with_Dexmedetomidine
Norso Medical Ltd. is the sole exclusive sales/service agent for:
Mindray Patient Monitors, Ultrasound, and Integration & Connectivity
Masimo Co Oximetry including SpHb, Sedline 4Ch EEG, O3 cerebral monitoring and other connected devices.
Masimo ISirona – Hospital automation platform for EMR Integration
LIDCO hemodynamic monitoring
Monivent® Neo 100 & Monivent® Neo Training
Gaumard Simulators for Healthcare Education
Clear Diamond Screen protection
ADC Range of Primary care devices
New Study Published on Masimo SpHb ® Continuous and Noninvasive Hemoglobin Monitoring Solution
New Prospective Study Finds That Masimo SpHb® Noninvasive and Continuous Hemoglobin Monitoring Can Help Provide Effective Blood Management in Patients Undergoing Major Surgery.
Norso Medical partner company – Masimo – today announced the findings of a prospective, double-blinded, randomized, controlled trial published in the Journal of the College of Physicians and Surgeons Pakistan. In the study, Dr. Sukriye Akdag and colleagues at Marmara University in Istanbul, Turkey assessed the impact of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® on blood transfusion management for adult patients undergoing elective major surgery with anticipated blood loss of 20% or more. The researchers found that the postoperative red blood cell (RBC) transfusion rate was lower, and the hemoglobin level of ICU patients higher, when monitored with SpHb in the operating room. They concluded, “SpHb can provide effective patient blood management in cases of major surgery.”1
Noting that delayed or unnecessary blood transfusions have been associated with increased mortality and morbidity, the researchers sought to evaluate the impact of continuous hemoglobin monitoring with Masimo SpHb, which offers continuous trending of hemoglobin levels, provided noninvasively and in real time. The researchers enrolled 120 patients aged 18-85 (ASA score I-III) scheduled for major surgery, divided randomly into an SpHb group (n=60) and a control group (n=60). There were no significant differences in the demographics or mean arterial pressure, heart rate, or arterial blood gas analysis between the groups. In the control group, patients’ hemoglobin was measured using conventional, intermittent blood sampling, analyzed with an ABL800Flex Radiometer, at the beginning, the second hour, the fourth hour, and the end of the operation. In the SpHb group, in addition to conventional blood sampling, patients’ SpHb values, pleth variability index (Masimo PVi®) and perfusion index (Pi) were noninvasively and continuously monitored with Masimo Radical-7® Pulse CO-Oximeters®; in the case of a sudden decrease in hemoglobin value, an additional blood gas analysis was performed. In both groups, transfusion was carried out when hemoglobin levels fell below 9 g/dL (per standard European Society of Anaesthesia recommendations) by blood gas analysis.
The researchers found that, comparing overall postoperative measurements, there were no significant differences between the groups in hemoglobin, platelet, or creatinine levels; nor in the amount of fresh frozen plasma, or platelet suspension transfused intraoperatively and postoperatively; nor in the amount of RBC units transfused intraoperatively. However, the postoperative RBC transfusion rate in the SpHb group was significantly lower (SpHb group: median 0 international units (IUs); control group: median 2 IUs; p=0.020).* Postoperative hemoglobin levels in SpHb group patients in the ICU were also statistically significantly higher (SpHb group: 8.41 g/dL ± 1.08 g/dL; control group: 7.75 g/dL ± 1.19 g/dL; p=0.033).
The investigators concluded, “SpHb measurement in major surgical cases can accompany conventional Hb measurement methods, allowing effective patient blood management practice. … Since this may decrease mortality and morbidity by reducing postoperative blood transfusion, the use of such an advanced monitoring method in major surgeries may increase patient safety.”
This study adds additional evidence to the growing literature on the value of continuous hemoglobin monitoring with SpHb. SpHb, as part of patient blood management programs, has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,2,3 reducing the units of red blood cells transfused per patient,4-6 reducing the time to transfusion,7 reducing costs,8 and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi).9 This evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.1-9 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.
SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
Further Details of the Study can be found here
Norso Medical Ltd. is the sole exclusive sales/service agent for:
-
Mindray Patient Monitors, Ultrasound, and Integration & Connectivity
-
Masimo Co Oximetry including SpHb, Sedline 4Ch EEG, O3 cerebral monitoring and other connected devices.
-
Masimo ISirona – Hospital automation platform for EMR Integration
-
LIDCO hemodynamic monitoring
-
Monivent® Neo 100 & Monivent® Neo Training
-
MDoloris Medical Systems
-
Lifecast Body Simulation (NI Only)
-
Clear Diamond Screen protection
-
ADC Range of Primary care devices
Norso Medical Signs Partnership Agreement with MDoloris Medical Systems
Norso Medical Limited is pleased to announce a new partnership with MDolores Medical Systems for the distribution of MDoloris Products within Northern Ireland and Republic of Ireland. MDoloris Medical Systems is the first worldwide company to be able to provide clinicians for continuous and non-invasive surgical stress monitoring medical devices of the patient’s parasympathetic tone.
Managing analgesia with our devices avoids and prevents the side effects such as analgesia overdosing, post-op acute pain, and further health complications. With MDoloris monitor guidance, clinical investigations have shown that patients wake up faster with lower pain scores.
Founded in 2012, Norso Medical is a leading All-Ireland Medical supply and service company specialising in Patient Monitoring, Ultrasound, Hemodynamic Monitoring and Co-Oximetry. Keith Wonnacott and Pat Whelan, Co-Directors / Founders of Norso
Medical said “We are proud to have partnered with MDolores Medical Systems and represent them in our market where we have synergy between our existing Partner in Masimo, Mindray and Lidco and the MDolores offering. Their technology is the result of 23 years of academic research and testament to their mission in providing provide technologies that allow clinicians a reliable, continuous, and non-invasive evaluation of their patient’s Autonomic Nervous System activity”
Pictured – Mr. Keith Wonnacott, Director Norso Medical and Mr. Zoltan Istok – Area Manager – MDoloris Medical Systems.
Link to MDoloris Website
Norso Medical partners with Gaumard to distribute simulation-based healthcare training solutions.
Norso Medical is excited to announce that we have entered into a distributor agreement with Gaumard, a leading manufacturer of simulation-based healthcare training solutions. This agreement will allow us to bring Gaumard’s cutting-edge products to healthcare institutions in the Republic of Ireland and Northern Ireland.
Simulation-based healthcare training has become increasingly important in recent years, as medical professionals seek to improve their skills in a safe, controlled environment. Gaumard has been at the forefront of this trend, designing and manufacturing simulation products that provide realistic patient scenarios for medical training.
With Gaumard’s products, medical professionals can practice a wide range of procedures and interventions on lifelike simulated patients, helping them to develop their skills and improve patient outcomes. Whether training for emergency situations, learning new surgical techniques, or practicing complex procedures, Gaumard’s products provide an invaluable resource for healthcare institutions.
As a distributor of Gaumard’s products and sitting alongside our other simulation partners Lifecast & Monivent, Norso Medical will be able to offer our customers access to some of the most advanced simulation technology on the market today. From full-body manikins with realistic breathing and pulse, to virtual reality training tools that simulate complex procedures, Gaumard’s products provide a wide range of options for healthcare training.
But it’s not just the technology that sets Gaumard apart. The company also places a strong emphasis on customer service and support, ensuring that their products are well-maintained and always up-to-date. This commitment to customer satisfaction is a key reason why Gaumard products are trusted by medical institutions around the world.
At Norso Medical, we share Gaumard’s commitment to providing exceptional customer service and support. We believe that our partnership with Gaumard will allow us to better serve our customers and provide them with the resources they need to succeed in their medical careers.
“Norso Medical is thrilled to announce our distributor agreement with Gaumard. We believe that this partnership will allow us to provide our customers with some of the most advanced simulation-based healthcare training solutions on the market today, and we look forward to working closely with Gaumard to support our customers throughout Ireland. Norso Medical is confident that we can help to bring the benefits of simulation-based healthcare training to even more medical professionals throughout Ireland” Keith Wonnacott & Pat Whelan, Directors, Norso Medical Ltd.
ESAIC Recommends Noninvasive, Continuous Hemoglobin Monitoring
Norso Medical partner company – Masimo – today announced that updated guidelines published by the European Society of Anaesthesiology and Intensive Care (ESAIC) highlight the value of noninvasive, continuous hemoglobin (Hb) monitoring in helping clinicians manage perioperative bleeding. Referencing studies using technologies such as Masimo SpHb®, the guidelines note that “the use of noninvasive Hb-monitoring methods may be a practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.”1
Noting that in this area of care it is “essential to remain informed by the latest evidence,” the ESAIC, which has pledged to revisit its perioperative blood management guidelines at least every five years, has just published its updated findings, the result of a systematic review of research published from 2015 to 2021. Noting that managing bleeding during surger
y is complex and “involves multiple assessment tools and strategies to ensure optimal patient care,” the guidelines cover numerous modalities, disciplines, scenarios, and patient populations – including how noninvasive, continuous hemoglobin monitoring offers a valuable way to improve blood management.
In the updated guidelines, the ESAIC notes a major drawback to measuring hemoglobin during surgery using blood gas analyzers and invasive blood sampling: “single measurements taken at different time points may not depict accurate values.” In addition, they note, excess blood sampling can lead to iatrogenic blood loss and hospital-acquired anemia.
While noninvasive hemoglobin monitoring is not intended to replace invasive blood sampling, it may offer a “practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.” The guidelines also note its value “for trend analysis and to monitor changes in addition to laboratory-measured Hb concentrations during the intervals between invasive blood sampling and Hb measurements.” The guidelines continue, “Having access to continuous measurements of Hb concentrations offers timely detection of changes in Hb concentrations and adjustment, if necessary, in the clinical setting.”
In their summary of the guidance derived from their systematic literature review, the g
uidelines also note that when severe bleeding and volume shifts are expected or occurring, “continuous noninvasive haemoglobin monitoring may be considered for trend analyses and for reducing blood sampling for invasive laboratory measurement of haemoglobin concentration, especially in children.”
Noting that in this area of care it is “essential to remain informed by the latest evidence,” the ESAIC, which has pledged to revisit its perioperative blood management guidelines at least every five years, has just published its updated findings, the result of a systematic review
of research published from 2015 to 2021. Noting that managing bleeding during surgery is complex and “involves multiple assessment tools and strategies to ensure optimal patient care,” the guidelines cover numerous modalities, disciplines, scenarios, and patient populations – including how noninvasive, continuous hemoglobin monitoring offers a valuable way to improve blood management.
In the updated guidelines, the ESAIC notes a major drawback to measuring hemoglobin during surgery using blood gas analyzers and invasive blood sampling: “single measurements taken at different time points may not depict accurate values.” In addition, they note
, excess blood sampling can lead to iatrogenic blood loss and hospital-acquired anemia. While noninvasive hemoglobin monitoring is not intended to replace invasive blood sampling, it may offer a “practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.” The guidelines also note its value “for trend analysis and to monitor changes in addition to laboratory-measured Hb concentrations during the intervals between invasive blood sampling and Hb measurements.” The guidelines continue, “Having access to continuous measurements of Hb concentrations offers timely detection of changes in Hb concentrations and adjustment, if necessary, in the clinical setting.”
In their summary of the guidance derived from their systematic literature review, the guidelines
also note that when severe bleeding and volume shifts are expected or occurring, “continuous noninvasive haemoglobin monitoring may be considered for trend analyses and for reducing blood sampling for invasive laboratory measurement of haemoglobin concentration, especially in children.”
Dr. William C. Wilson, Chief Medical Officer, Masimo, added, “With laboratory measurements, and even with bedside point-of-care hemoglobin testing, results are intermittent, sampling errors can occur, and performing these tests can be distracting during complex cases and while caring for critically ill patients. SpHb monitoring provides real-time v
isibility to hemoglobin levels throughout the continuum of care and has the advantages of trend analysis as well as reductions in workload and delay, enabling clinicians to adjust blood management and observe results simultaneously.”
Joe Kiani, Founder and CEO of Masimo, said, “Since its introduction 15 years ago, we’ve been heartened to see more and more clinicians around the world adopt SpHb as their standard of care, more and more clinical studies demonstrate its utility, and more and more esteemed organizations like ESAIC recognize the benefits of noninvasive h
emoglobin monitoring. The result of years of development and continued refinement, powered by our expertise in advanced signal processing techniques, SpHb plays a critical role in our mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.”
SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
Further Details of the Study can be found here
Norso Medical Ltd. is the sole exclusive sales/service agent for:
Mindray Patient Monitors, Ultrasound, and Integration & Connectivity
Masimo Co Oximetry including SpHb, Sedline 4Ch EEG, O3 cerebral monitoring and other connected devices.
Masimo ISirona – Hospital automation platform for EMR Integration
LIDCO hemodynamic monitoring
Monivent® Neo 100 & Monivent® Neo Training
MDoloris Medical Systems
Lifecast Body Simulation (NI Only)
Gaumard Simulators for Healthcare Education
Clear Diamond Screen protection
ADC Range of Primary care devices
Norso Medical Proudly Sponsors Two Leading Critical Care Events
Norso Medical is excited to announce its sponsorship of two important events in the critical care field: The Critical Care Reviews Meeting and the 6th International ARDS Conference.
The Critical Care Reviews Meeting, which is being held in Titanic Belfast, Belfast, Northern Ireland, is a niche meeting that hosts major critical care trial results, reviews the best trials of the preceding 12 months, and discusses all aspects of trial methodology, design, interpretation, and publishing. This meeting provides a unique opportunity for attendees to engage in discussions and debates with experts in the field of critical care research.
The 6th International ARDS Conference, which will take place in Dublin from 19 – 21 June 2023, will offer a full scientific program bringing together leading faculty experts in the field of ARDS from around the world. This conference will discuss basic mechanisms of acute lung injury, progress in clinical research for pathogenesis and prognosis, and current and future clinical trials for ARDS, focusing on challenges and opportunities. Attendees will gain valuable insights into the latest research and advancements in ARDS treatment.
Norso Medical is proud to sponsor these two events and to support the critical care community. We believe that these events will provide valuable opportunities for researchers, clinicians, and industry professionals to exchange ideas, collaborate on research, and advance the field of critical care.
Announcing the sponsorship – Norso Medical directors Keith Wonnacott and Pat Whelan commented that “Norso Medical is committed to supporting research and development in the critical care field. We are excited to be a part of these important events and to contribute to the advancement of critical care research.
We look forward to meeting with attendees at both events to discuss our commitment to respiratory care and our products and services that support critical care treatment”.