Medical Devices-Evidence and Research最新文献

{"title":"Initial Validation of the NOL Nociception Level Index^® Monitoring System in Black and Multiracial People.","authors":"Rachel Weissbrod, Charlene Blake","doi":"10.2147/MDER.S492561","DOIUrl":"10.2147/MDER.S492561","url":null,"abstract":"<p><p>The NOL-Nociception Level Index^® is a multiparameter index, based on artificial intelligence for the monitoring of nociception (physiological pain response) during anesthesia that has recently been authorized by the FDA. The monitor utilizes continuous streams of information from a finger probe comprising four sensors, including photoplethysmography, to provide a personalized nociception score on a scale of 0-100. Recent studies have suggested racial bias in pulse oximeter measurements due to the effect of melanin levels on photoplethysmography measurements. Therefore, there is a need to clinically validate new monitoring technologies in patients of all skin tones. The performance of the NOL scale in 8 patients that self-identified as Black or multiracial was compared to a database of 447 consented patients, assessing the response to surgical events at different levels of intensity. The descriptive, pilot data suggest that NOL performance in Black and multiracial patients is not different from the performance shown for the large database. Larger studies utilizing recognized skin tone scales to ensure accurate assessment of skin pigmentation are planned for the future.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"465-469"},"PeriodicalIF":1.3,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570531/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142669311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential of Aluminum Drug Packages with Press-Through Packaging Considering Usability for a Wide Range of Users.","authors":"Kiyoshi Kubota, Morio Shimada, Hiroyuki Ura, Kiyomi Sadamoto","doi":"10.2147/MDER.S482277","DOIUrl":"10.2147/MDER.S482277","url":null,"abstract":"<p><strong>Purpose: </strong>Press-through packages (PTPs) are frequently used for the packaging of prescription drugs in Japan. However, tablets or capsules packaged in PTPs may become unstable and difficult to store. Therefore, aluminum pouches (pillow packages) are applied as an additional packaging option. Especially for 10-sheet tablet (capsule) PTPs, there are many opportunities for health-care professionals (mainly pharmacists) to open pillow packages during the dispensing process. However, aluminum pouches (pillow packages) that are easy to open and store appropriately by not only pharmacists, but also patients, are needed.</p><p><strong>Methods: </strong>A 100-unit PTP (pillow package) with conventional specifications <b>①</b> and two other products (<b>②</b>: open vertically by a wavy processed half-cut and <b>③</b>: pinch the backlining open) were developed with the aim of improving the ease of opening. The study participants, consisting of pharmacists and patients, performed tasks such as opening and taking drugs out of the PTP for each sample, and evaluated the differences in usability.</p><p><strong>Results: </strong>The results of a sensory test revealed that pharmacists rated products <b>②</b> and <b>③</b> higher than product <b>①</b>. On the other hand, patients, including those with weak grip and pinching strengths, rated <b>③</b> highly, confirming the superiority of usability in the order of <b>③, ②</b>, and <b>①</b>. In addition, item <b>③</b> was successfully opened by all patients.</p><p><strong>Conclusion: </strong>The present results indicated the superiority of the developed pillow packaging, which enables pharmacists to save time in the dispensing process. In addition, product ③ was evaluated highly by patients, especially those with disabilities, for its ease of use not only in terms of opening, but also storage. Sensory testing by actual users applying ergonomic methods enabled a multifaceted evaluation of the products and provided insights into the actual status of pharmacists' dispensing work (product issues) and patients' daily medication use.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"441-453"},"PeriodicalIF":1.3,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Application Effect of Fine Management Combined with Man-Machine Fixation Mode in Reducing the Attrition Rate of Laparoscopic Instruments-A Non-Randomized, Concurrent Controlled Study.","authors":"Shujin Xia, Xuelu Wang, Chenying Xu, Lina Bai, Yuehong Li","doi":"10.2147/MDER.S479048","DOIUrl":"https://doi.org/10.2147/MDER.S479048","url":null,"abstract":"<p><strong>Purpose: </strong>To explore the effect of fine management combined with man-machine fixation mode in reducing the attrition rate of laparoscopic instruments.</p><p><strong>Methods: </strong>This is a non-randomized, concurrent controlled study, from December 1, 2023, to May 1, 2024, the use of 4 laparoscopic instruments in the operating room which belongs to shanghai first maternity and infant hospital was analyzed. The instruments were divided into two groups, and the control group was managed by conventional methods. The observation group implemented with fine management combined with man-machine fixed mode. We used instrument attrition rate and physician satisfaction as outcome indicators.</p><p><strong>Results: </strong>In this study, four laparoscopic instruments were investigated, and a total of 858 cases were used, including 429 cases in the control group (machine 1, machine 2) and 429 cases in the observation group (machine 3, machine 4). After the implementation of refined management combined with man-machine fixed mode, the observation group had significantly lower attrition rate and failure rate of laparoscopic instruments than the control group, including insufficient instrument preparation (p = 0.000), unstable light source (p = 0.012), air leakage (p = 0.000), screen color distortion (p = 0.040), and blurred visual field (p = 0.000). The satisfaction of doctors in the observation group was significantly higher than that in the control group, including preoperative preparation, process cooperation, operation proficiency, trouble solving ability, instrument debugging ability, communication and service attitude (p < 0.01).</p><p><strong>Conclusion: </strong>The use of fine management combined with man-machine fixed mode in the management of laparoscopic instruments in the operating room can effectively reduce the incidence of instrument attrition rate, improve the efficiency of surgery, and the economic benefit of the hospital, which is worthy of popularization and application.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"455-463"},"PeriodicalIF":1.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11552511/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patients with Growth-Related Disorders and Caregivers Prefer the Somapacitan Device to the Somatrogon Device: Results from a Randomized Crossover Study Assessing Device Preference and Ease of Use Following Simulated Injections.","authors":"Shahid Akhtar, Birgitte Berg, Johan Medina, Maya Nicole Gonczi, Sophie Hamilton, Emily Hildebrand, Nicky Kelepouris, Jesper Skov Neergaard, Claus Sværke, Gitte Ter-Borch, Niklas Kahr Rasmussen","doi":"10.2147/MDER.S484354","DOIUrl":"10.2147/MDER.S484354","url":null,"abstract":"<p><strong>Purpose: </strong>Adherence to growth hormone treatment is known to affect growth outcomes. Both device preference and ease of use have been shown to affect treatment adherence. In this study, we assessed device preference and ease of use with two long-acting growth hormones, somapacitan (Sogroya^®, Novo Nordisk A/S) and somatrogon (Ngenla^®, Pfizer).</p><p><strong>Patients and methods: </strong>In a randomized, crossover study conducted between September 20 and November 2, 2023, we recruited 33 adolescents with a growth-related disorder, and 37 caregivers, at six locations in the United States. Each participant was trained in the use of both devices and asked to perform a simulated injection. Device training time, preparation and injection time, and injection completeness were recorded. Participants also completed the Device Handling and Preference Questionnaire (DHPAQ) to indicate their device preference and ease of use opinions. Following conclusion of the \"standard\" visit, 10 adolescents and 10 caregivers were randomly selected to participate in a sub-study to validate the relevance, comprehensiveness, and comprehension of the DHPAQ.</p><p><strong>Results: </strong>The majority of participants (84.3%; 95% confidence interval [CI]: 74;92) preferred the somapacitan device to the somatrogon device (p < 0.0001). Almost all (98.6%; 95% CI: 92;100) participants answered that the somapacitan device was easy or very easy to use, while three-quarters (74.3%; 95% CI: 62;84) answered the same for the somatrogon device. Average training and injection times were lower for the somapacitan device than for the somatrogon device. Also, more patients successfully completed the injection with the somapacitan device than with the somatrogon device (97.1% vs 92.9%). Cognitive debriefing interviews indicated the DHPAQ was relevant, comprehensive, and fully comprehended.</p><p><strong>Conclusion: </strong>The somapacitan device was preferred to the somatrogon device by a majority of participants. More participants considered the somapacitan device to be easy or very easy to use than the somatrogon device.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"427-439"},"PeriodicalIF":1.3,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531717/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"May Glymphatic Drainage Improve Life Quality in Progressive Multiple Sclerosis Outpatients?","authors":"Sandro Mandolesi, Tarcisio Niglio, Chiara Lenci","doi":"10.2147/MDER.S480815","DOIUrl":"10.2147/MDER.S480815","url":null,"abstract":"<p><strong>Background: </strong>The cerebral fluid-dynamic system plays a critical role in maintaining brain health and function. Recent studies identify the glymphatic system as primarily responsible for removing waste products and toxins from brain tissue. In recent years, we have achieved beneficial improvements in MS patients' symptoms and lifestyle using a specific Fluid Dynamic Intensive MAM (FD-MAM) protocol.</p><p><strong>Methods: </strong>We treated 40 outpatients with progressive MS, aged 45-55 years and with EDSS scores from 6 to 9. We applied FD-MAM in 10 daily sessions over two weeks. Before and after glymphatic drainage by FD-MAM, we assessed each patient's clinical status and quality of life using six validated questionnaires.</p><p><strong>Results: </strong>Data from the six validated questionnaires administered to the 40 MS patients show an improvement in 83% of the scores. At the same time, we observed a shift from pathological to physiological values in 50% of the pathological scores after 10 sessions of FD-MAM protocol.</p><p><strong>Conclusion: </strong>This study confirms the positive improvements on life quality in outpatients with progressive multiple sclerosis after one cycle of Fluid Dynamic Intensive MAM (FD-MAM) protocol. Initial follow-up on few patients treated with the FD-MAM protocol suggests that the results persist for six to ten months post-treatment. Future detailed studies, on MS outpatients' larger cohort, are essential to assess the duration of results and its effect on glymphatic system.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"417-426"},"PeriodicalIF":1.3,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intelligent Generating Controller a Desflurane Concentration Value Which Helps to Decrease Blood Pressure.","authors":"Pawel Ratajczyk, Bartosz Dominikowski, Agnieszka Czylkowska, Bartlomiej Rogalewicz, Cezary Kulak, Tomasz Gaszynski","doi":"10.2147/MDER.S483837","DOIUrl":"10.2147/MDER.S483837","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of the article is to determine the appropriate concentration of desflurane to effectively counteract the increase in blood pressure resulting from surgical stress. In medical practice, this increase is often limited by using additional doses of opioid drugs. Additional medications or higher doses of those already used may adversely affect your health. During anesthesia, physician must note the use of drugs and remember them, especially those that he has recently administered, which affect his concentration. For this purpose, the authors decided to propose support for the selection of desflurane concentration so that frequent use of opioid drugs is not necessary. The authors used a system based on AI issues to accomplish this task. The learned system supports the anesthesiologist's work by imitating him.</p><p><strong>Patients and methods: </strong>The proposed method for selecting the desflurane concentration is based on a fuzzy controller. This system includes a learning mechanism that allows for minimizing the operating error. The main advantage of this system is the ability to build a function allowing the selection of anesthesia parameters without knowledge of the mathematical description of the process. To accomplish this task, you need an expert who will provide information in the construction of logical if-then sentences (points in space). The fuzzy controller connects the points in the consideration space appropriately, generating a hypersurface. The algorithm test was performed only by computer without the participation of patients.</p><p><strong>Results: </strong>The operation of the proposed algorithm was verified by computer simulation. The authors of the article analyzed the compliance of the obtained results with the table provided by the expert. The desflurane concentration values obtained by computer simulation are similar to those given in the table Minimal driver error does not affect the patient's clinical response. This error results from the functions used in the fuzzy system and its settings. The results of the performance test of the proposed algorithm are presented in a time course, and it has the shape of a step function. The work proposes a function that allows you to enter the time needed for the body's reaction to reach the desired <i>E_tdes</i> level.</p><p><strong>Conclusion: </strong>In this study, a controller was created to support the selection of the concentration of desflurane allowing for a reduction in blood pressure (resulting from surgical stress). The results obtained by computer simulation provide valuable insights for optimizing anesthesia. This system can also be used as an important simulation program for teaching purposes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"401-415"},"PeriodicalIF":1.3,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of a Novel Posterior Integrated Transfixation Sacroiliac Joint Fusion Approach to the Posterolateral and Lateral Approaches: A Cadaveric Biomechanical and Computational Analysis of the Fixation, Invasiveness, and Fusion Area.","authors":"Oluwatodimu Richard Raji, Joshua H Tandio, Sarah Mayer, Alexander Escobar, Brett A Himmelwright, Douglas P Beall, David L Caraway, Jeremi M Leasure","doi":"10.2147/MDER.S474734","DOIUrl":"https://doi.org/10.2147/MDER.S474734","url":null,"abstract":"<p><strong>Purpose: </strong>To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.</p><p><strong>Methods and materials: </strong>Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.</p><p><strong>Results: </strong>The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes (<i>P</i> > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, <i>P</i> <0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P<0.10), introduced 200%-270% more implant surface to the joint space (P<0.01) and decorticated 75%-375% more joint surface area (<i>P</i><0.01).</p><p><strong>Conclusion: </strong>The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"385-399"},"PeriodicalIF":1.3,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548270","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigation into the Acceptability of Moderate-to-Large Volume Subcutaneous Injections in Healthy Volunteers: Results from a Single-Center Randomized Controlled Study.","authors":"Chika Akinseye, Andrew Fiorini, Emily Louise Jarvis, Michelle Fry, Abid Raza, Sara Soleman, Stephanie Igwe, Mark Palmer","doi":"10.2147/MDER.S479507","DOIUrl":"10.2147/MDER.S479507","url":null,"abstract":"<p><strong>Purpose: </strong>Therapeutic proteins are often delivered by subcutaneous (SC) autoinjector to enable self-administration. Autoinjectors typically deliver up to 1 mL injected volumes per dose. Delivery of larger volumes may be limited by injection site discomfort, including pain, swelling, and redness. Delivery at a slower rate may mitigate this discomfort. This single-center, randomized, crossover study evaluated the acceptability and tolerability of varying volumes and delivery rates of SC saline in healthy volunteers.</p><p><strong>Patients and methods: </strong>Eligible participants were adults (18-65 years) with a body mass index of 18.5-32.0 kg/m². Participants (N = 24) were randomized to multiple sequences of infusions over five visits, with infusions ranging from 1 to 5 mL at rates of 1.50-6.00 mL/minute (min) and including a 1 mL SC infusion in 10 seconds (s) at a rate of 6.00 mL/min. The primary objective was to identify acceptable volume and delivery rates of SC saline, as assessed by visual analogue scale (VAS) pain scores, a tolerability and acceptability questionnaire, and infusion leakage.</p><p><strong>Results: </strong>Infusions that met the acceptability criteria were 1 mL in 10s, 4 mL in 58s, and 3 mL in 2 mins. Higher delivery volumes and rates were associated with higher VAS pain scores but remained within the VAS acceptability criteria.</p><p><strong>Conclusion: </strong>These findings may support the development of larger-volume injectors for self-administration of future medicines.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"369-384"},"PeriodicalIF":1.3,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11522010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Problems Related to Endotracheal Intubation as an Input for the Design of a New Endotracheal Tube.","authors":"Gorka Ramirez, Miguel Angel Campanero, Ane Miren Zaldua, Nerea Jauregizar","doi":"10.2147/MDER.S475964","DOIUrl":"10.2147/MDER.S475964","url":null,"abstract":"<p><strong>Objective: </strong>The purpose of the current review is to identify the main problems of endotracheal intubation, which will serve as a basis for the design requirements for a novel endotracheal tube.</p><p><strong>Methodology: </strong>A PICO systematic search was conducted in PubMed up to December 2021 to identify issues related both to the endotracheal intubation procedure and device-specific factors.</p><p><strong>Results: </strong>Two primary categories of problems were identified during endotracheal intubation: a) Issues related to laryngotracheal symptoms such as cough, hoarseness, aphonia, dysphonia, dysphagia, swallowing difficulties and the risk of stenosis with long-term intubation. The underlying pressure, abrasion and/or decubitus phenomena should be considered in a new design approach. b) Issues related to the cuff sealing and microaspirations, where the risk of ventilator-associated pneumonia (VAP) highlights the need to improve the design.</p><p><strong>Discussion & conclusion: </strong>This review has yielded valuable input for rethinking the design of endotracheal tubes to ensure an efficient and safe airway. This new design should focus on the protection of anatomical structures, avoid or reduce the phenomena of laryngotracheal symptoms, and even reduce the risk of ventilator-associated-pneumonia (VAP) and/or prevent the need for certain tracheostomies.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"349-367"},"PeriodicalIF":1.3,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11514703/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142523308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discrepancies in CDE and Measured Phaco Tip Energy: Comparison of Energy Produced in Longitudinal and Torsional Ultrasound Using Calorimetry.","authors":"Reiker G Ricks, Ivan A Cardenas, Jenna L Jensen, Tanner K Nelson, Randall J Olson, Jeff H Pettey","doi":"10.2147/MDER.S484843","DOIUrl":"10.2147/MDER.S484843","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to investigate the differences between the heat energy produced during cataract surgery and Cumulative dissipated energy (CDE). CDE is often used as a medium for understanding the energy delivered to the eye during cataract surgery. However, the actual energy produced at the tip level of the tip is not well understood. We propose that a discrepancy may exist between the CDE reported by the surgical machine and the actual energy delivered to the eye.</p><p><strong>Methods: </strong>About 50 mL of distilled water were degassed and placed in an isobaric calorimeter. Using the Alcon Centurion and Ozil handpiece fitted with the balanced tip, an investigator immersed the phaco tip into the water and pressed the foot pedal to position 3. The device was set to 100% continuous power, vacuum to 0 mmHg, with aspiration 12 mL/min aspiration. To prevent system changes in the system within the calorimeter, the aspiration tubing was occluded. Temperature change recorded by another investigator was observed from 0 to 60 seconds. After 60 seconds the first researcher immediately released the pedal and removed the phaco tip from the water. Trials were performed 10 times using solely torsional or longitudinal settings and averaged. CDE also was recorded and averaged.</p><p><strong>Results: </strong>No significant difference was seen in the temperature change or energy calculated in Joules between ultrasound modalities, with torsional producing a magnitude of 163 J and longitudinal producing 172 J (P = 0.2). However, the CDE generated in the 60 seconds period was significantly different, with a magnitude of 61 for longitudinal compared to 24 for torsional (P < 0.001).</p><p><strong>Conclusion: </strong>Significantly more energy was generated using torsional ultrasound than longitudinal at the tip level of the tip. CDE did not appear to accurately reflect these differences. This suggests that other factors should be considered when evaluating CDE and surgical outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":"17 ","pages":"339-348"},"PeriodicalIF":1.3,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11492905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142485981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}