Medical Devices-Evidence and Research最新文献

{"title":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Response to Letter].","authors":"Andy Kranenburg, Gabriel Garcia-Diaz, Judson H Cook, Michael Thambuswamy, Whitney James, David Stevens, Adam Bruggeman, Ying Chen, Robyn Capobianco, W Carlton Reckling, Joel D Siegal","doi":"10.2147/MDER.S388473","DOIUrl":"https://doi.org/10.2147/MDER.S388473","url":null,"abstract":"1Southern Oregon Orthopedics, Medford, OR, USA; 2OrthoSpine Advance Health, Inc, Merced, CA, USA; 3Central Texas Brain and Spine, Austin, TX, USA; 4Oklahoma Spine & Brain Institute, Tulsa, OK, USA; 5James Marco Health, Prescott, AZ, USA; 6Utah Spine Specialists, Bountiful, UT, USA; 7Texas Spine Care Center, San Antonio, TX, USA; 8OrthoNeuro Inc, New Albany, OH, USA; 9SI-BONE Inc, Santa Clara, CA, USA; 10Key Clinics LLC, Mayfield Heights, OH, USA","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"367-369"},"PeriodicalIF":1.3,"publicationDate":"2022-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bd/24/mder-15-367.PMC9587730.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40568923","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":"Revision of Failed Sacroiliac Joint Posterior Interpositional Structural Allograft Stabilization with Lateral Porous Titanium Implants: A Multicenter Case Series [Letter].","authors":"Timothy R Deer, Douglas P Beall, Steven M Falowski","doi":"10.2147/MDER.S385627","DOIUrl":"https://doi.org/10.2147/MDER.S385627","url":null,"abstract":"","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"365-366"},"PeriodicalIF":1.3,"publicationDate":"2022-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/80/f0/mder-15-365.PMC9586172.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40675605","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":"Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework.","authors":"Omar Kheir,&nbsp;Alexis Jacoby,&nbsp;Stijn Verwulgen","doi":"10.2147/MDER.S375977","DOIUrl":"https://doi.org/10.2147/MDER.S375977","url":null,"abstract":"<p><strong>Introduction: </strong>Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices' development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards' requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations' compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products' chances of success.</p><p><strong>Methods: </strong>A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.</p><p><strong>Results: </strong>Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.</p><p><strong>Discussion: </strong>A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"349-363"},"PeriodicalIF":1.3,"publicationDate":"2022-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/9f/3b/mder-15-349.PMC9507292.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33484276","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":"Lens Autofluorescence Based Advanced Glycation End Products (AGEs) Measurement to Assess Risk of Osteopenia Among Individuals Under the Age of 50.","authors":"Shaoyun Li,&nbsp;Yuefei Li,&nbsp;Xiyan Xu,&nbsp;Jian Shao,&nbsp;Ruifeng Xie,&nbsp;Sheng Liu,&nbsp;Li Peng,&nbsp;Jin Wang,&nbsp;Kaixin Zhou,&nbsp;Huyi Feng","doi":"10.2147/MDER.S381115","DOIUrl":"https://doi.org/10.2147/MDER.S381115","url":null,"abstract":"<p><strong>Introduction: </strong>Simple non-invasive biomarker is urgently needed to detect the largely silent osteopenia in order to prevent osteoporosis-related fracture later in life. The accumulation of advanced glycation end products (AGEs) has been related to reduced bone density and osteoporotic fractures. Whether lens autofluorescence (LAF) based AGEs (LAF-AGEs) measurement could be used to assess the risk of osteopenia is aimed to investigate in this paper.</p><p><strong>Methods: </strong>Through routine health examination, 368 individuals under the age of 50 were enrolled. A dual-energy X-ray absorptiometry (DXA) device was used to measure bone mineral density (BMD) of the forearm and determine osteopenia. AGE levels were derived with LAF along with the other demographic and laboratory parameters. After deriving the age-adjusted AGE levels (AALs), a linear regression analysis and an ordered logistic regression analysis were applied to examine the associations between osteopenia and LAF-AGEs as well as AALs.</p><p><strong>Results: </strong>Negative correlations (Pearson r = -0.16, p < 0.001) were found between LAF-AGEs and T-scores. Higher AALs were significantly associated (p = 0.004) with escalated level of osteopenia in the ordered logistic analysis.</p><p><strong>Discussion: </strong>After reviewing the relevant studies, it is concluded that LAF-AGE is a more stable measure of long-term metabolic dysfunction than circulating AGE. LAF-AGEs are a valid, practical and non-invasive parameter for osteopenia risk evaluation. Further studies with longer follow-up will be helpful to clarify its effectiveness for osteoporosis risk assessment.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"341-347"},"PeriodicalIF":1.3,"publicationDate":"2022-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/aa/e4/mder-15-341.PMC9467441.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40359285","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":"Retrospective Comparison of Clinical and Economic Outcomes of Non-Donor Patients Undergoing Radical Nephrectomy Using One of Two Different Linear Stapler Technologies for Transection of the Renal Vessels: Fixed-Height Gripping Surface Reloads vs Variable-Height Reloads.","authors":"Stephen S Johnston,&nbsp;Barbara H Johnson,&nbsp;Divya Chakke,&nbsp;Sanjoy Roy,&nbsp;Philippe Grange,&nbsp;Esther Pollack","doi":"10.2147/MDER.S372629","DOIUrl":"https://doi.org/10.2147/MDER.S372629","url":null,"abstract":"<p><strong>Purpose: </strong>To compare outcomes of non-donor patients undergoing radical nephrectomy using fixed-height gripping surface (FHGS) vs variable-height Tri-Staple™ (VHTS) reloads for transection of the renal vessels.</p><p><strong>Patients and methods: </strong>Using the Premier Healthcare Database of US hospital discharge records, we selected non-donor patients undergoing inpatient radical nephrectomy with dates of admission between 1 October 2015, and 31 December 2020 (first=index admission). The primary outcome was in-hospital hemostasis-related complications (hemorrhage, acute posthemorrhagic anemia, and/or procedure to control bleeding) during the index admission. Secondary outcomes included index admission intraoperative injury, blood transfusion, conversion from minimally invasive to open surgery, total hospital costs, length of stay (LOS), discharge status, and mortality as well as 30-day all-cause inpatient readmission. We used stable balancing weights to balance the FHGS and VHTS groups on numerous patient, procedure, and hospital/provider characteristics, allowing a maximum post-weighting standardized mean difference ≤0.01 for all covariates; we also exactly matched the groups on laterality (right vs left kidney) and intended surgical approach (open, laparoscopic, robotic). We used bivariate multilevel mixed-effects generalized linear models accounting for hospital-level clustering to compare the study outcomes between the FHGS and VHTS groups.</p><p><strong>Results: </strong>After weighting, the FHGS and VHTS groups comprised 2952 and 795 patients, respectively. The observed incidence proportion of the primary outcome of hemostasis-related complications during the index admission was similar between the groups (8.6% for FHGS vs 9.0% for VHTS, difference 0.4% [95% CI -3.2% to 2.5%], <i>P</i>=0.808). Differences between the FHGS and VHTS groups were not statistically significant for any of the secondary outcomes.</p><p><strong>Conclusion: </strong>Endoscopic surgical staplers have become common for transection of the renal vessels during radical nephrectomy, with FHGS and VHTS being the predominant reload types. In this retrospective study of 3747 non-donor patients undergoing radical nephrectomy, use of FHGS vs VHTS reloads was associated with similar clinical and economic outcomes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"317-328"},"PeriodicalIF":1.3,"publicationDate":"2022-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/8b/a2/mder-15-317.PMC9450510.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33461347","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":"Evaluation of Common Nasal Cannulas in Neonatal Noninvasive Ventilation (NIV) Using a Novel Neonatal Nasal Model.","authors":"Ulf Borg,&nbsp;Jeffrey Aviano,&nbsp;Milan Ginani,&nbsp;Kun Li","doi":"10.2147/MDER.S374418","DOIUrl":"https://doi.org/10.2147/MDER.S374418","url":null,"abstract":"<p><strong>Purpose: </strong>Non-invasive ventilation (NIV) may reduce intubation rates and be especially beneficial in the care of preterm infants, in addition to other care modalities. Currently, ventilators do not display the pressure at the nares but the pressure in the ventilator tubing system. There are several nasal cannulas available for use to deliver NIV. The purpose of this study was to compare the inspiratory pressure on the ventilator to the measured pressure delivered at the nares using three cannula brands (Manufacturer A, Fisher & Paykel; Manufacturer B, Neotech RAM; and Manufacturer C, Hudson RCI).</p><p><strong>Patients and methods: </strong>This bench study utilized a 3D printed nasal model, including nares in multiple sizes to accommodate all nasal prongs studied. The nasal adaptors were connected to neonatal test lungs, to simulate patient breathing. Multiple sizes of nasal cannulas from the three manufacturers were tested for inspiratory vs delivered pressure at the patient side of the cannula, using eight combinations of ventilator settings. Each nasal cannula was tested on six Puritan Bennett™ 980 ventilators.</p><p><strong>Results: </strong>The measured delivered pressure at the nares was consistently lower than the clinician-set inspiratory pressure. Across all ventilator settings, 7 of the 11 cannulas delivered significantly less pressure at the nares compared to the inspiratory ventilator pressure (p < 0.01). For each cannula, as inspiratory pressure increased, the difference between delivered and inspiratory pressures also increased. The cannula from Manufacturer B consistently demonstrated the greatest differences between set inspiratory and delivered pressures for each ventilator setting.</p><p><strong>Conclusion: </strong>This study demonstrated substantial differences between ventilator inspiratory pressure and measured delivered pressure, which may have clinical significance. Being unaware of the actual airway pressure delivered to the patient may lead to erroneous adjustments to the level of ventilator pressure, which may be especially consequential to those with delicate and developing respiratory systems.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"307-315"},"PeriodicalIF":1.3,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5e/ae/mder-15-307.PMC9444233.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33448569","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":"Cold Plasmamed Beam as a Supporting Treatment of Soft Tissue Injuries in Severe Covid-19 Patients: A Preliminary Report.","authors":"Thanh Xuan Nguyen,&nbsp;Duc Hanh Nguyen,&nbsp;Truong Phu Ho-Man,&nbsp;Vinh Duc An Bui,&nbsp;Phuoc Ngoc Phan","doi":"10.2147/MDER.S372916","DOIUrl":"https://doi.org/10.2147/MDER.S372916","url":null,"abstract":"<p><strong>Background: </strong>Cold plasma has many characteristics that allow for effective wound healing. Due to its efficacy, we have applied it in treating patients with severe Covid-19 who have soft tissue skin lesions and diseases including burns, pressure ulcers, shingles, and contact or atopic dermatitis. This study aims to assess the general characteristics of Covid-19 patients with soft tissue lesions and to conduct a fundamental evaluation of the efficacy of cold plasmamed beams in treating soft tissue wounds in patients with severe Covid-19.</p><p><strong>Methods: </strong>This prospective study was conducted on 20 severe Covid-19 patients with soft tissue lesions at the Intensive Care Center for Covid-19 of Hue Central Hospital in Ho Chi Minh City from September 25 to November 11, 2021. These patients was performed cold plasma irradiation at any stage of wound progression, including new injuries and chronic wounds.</p><p><strong>Results: </strong>Among 915 severe Covid-19 patients treated at our center, 20 patients had soft tissue lesions. Grade I, II, and III pressure ulcers accounted for 70% of the 20 cases of soft tissue lesions and 1.53% of the total patients at the time of the survey. Pressure ulcers were present in only 0.55% of patients (5/915 patients). Eleven out of 20 patients (55.0%) had lesions before admission, and 9 (45.0%) had lesions that appeared after admission. After 14 days of treatment, 14/20 patients had complete epithelialization (70%), and in 18/20 patients, wound exudation had ceased. The wounds became painless; after 3 weeks, the rashes had completely disappeared.</p><p><strong>Conclusion: </strong>The study emphasizes that irradiation with cold plasma contributes to the wound healing process.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"277-283"},"PeriodicalIF":1.3,"publicationDate":"2022-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3c/29/mder-15-277.PMC9394517.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40413538","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":"Use of a Portable Electronic Interface Improves Clinical Handoffs and Adherence to Lung Protective Ventilation.","authors":"Neil R Euliano, Paul Stephan, Konstantinos Michalopoulos, Michael A Gentile, A Joseph Layon, Andrea Gabrielli","doi":"10.2147/MDER.S372333","DOIUrl":"10.2147/MDER.S372333","url":null,"abstract":"<p><strong>Background: </strong>Mechanical ventilation (MV) is used to support patients with respiratory impairment. Evidence supports the use of lung-protective ventilation (LPV) during MV to improve outcomes. However, studies have demonstrated poor adherence to LPV guidelines. We hypothesized that an electronic platform adapted to a hand-held tablet receiving real-time ventilatory parameters could increase clinician awareness of key LPV parameters. Furthermore, we speculated that an electronic shift-change tool could improve the quality of clinician handoffs.</p><p><strong>Methods: </strong>Using a specially designed Wi-Fi dongle to transmit data from three ventilators and a respiratory monitor, we implemented a system that displays data from all ventilators under the care of a Respiratory Care Practitioner (RCP) on an electronic tablet. In addition, the tablet created a handoff checklist to improve shift-change communication. In a simulated ICU environment, we monitored the performance of eight RCPs at baseline and while using the system.</p><p><strong>Results: </strong>Using the system, the time above guideline Pplat decreased by 74% from control, and the time outside the VT range decreased by 60% from control, p = 0.007 and 0.015, respectively. The handoff scores improved quality significantly from 2.8 to 1.6 on a scale of 1 to 5 (1 being best), p = 0.03.</p><p><strong>Conclusion: </strong>In a simulated environment, an electronic RT tool can significantly improve shift-change communication and increase the RCP's level of LPV adherence.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"263-275"},"PeriodicalIF":1.3,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/33/48/mder-15-263.PMC9362905.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40690125","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":"Biomechanical and Physiological Evaluation of Respiratory Protective Equipment Application.","authors":"Silvia Caggiari,&nbsp;Dan L Bader,&nbsp;Finn Foxell,&nbsp;Nicholas Pipe,&nbsp;Seana Couch,&nbsp;Abbie Turner,&nbsp;Peter R Worsley","doi":"10.2147/MDER.S370142","DOIUrl":"https://doi.org/10.2147/MDER.S370142","url":null,"abstract":"<p><strong>Purpose: </strong>Respiratory protective equipment is widely used in healthcare settings to protect clinicians whilst treating patients with COVID-19. However, their generic designs do not accommodate the variability in face shape across genders and ethnicities. Accordingly, they are regularly overtightened to compensate for a poor fit. The present study aims at investigating the biomechanical and thermal loads during respirator application and the associated changes in local skin physiology at the skin-device interface.</p><p><strong>Materials and methods: </strong>Sixteen healthy volunteers were recruited and reflected a range of gender, ethnicities and facial anthropometrics. Four single-use respirators were evaluated representing different geometries, size and material interfaces. Participants were asked to wear each respirator in a random order while a series of measurements were recorded, including interface pressure, temperature and relative humidity. Measures of transepidermal water loss and skin hydration were assessed pre- and post-respirator application, and after 20 minutes of recovery. Statistical analysis assessed differences between respirator designs and associations between demographics, interface conditions and parameters of skin health.</p><p><strong>Results: </strong>Results showed a statistically significant negative correlation (p < 0.05) between the alar width and interface pressures at the nasal bridge, for three of the respirator designs. The nasal bridge site also corresponded to the highest pressures for all respirator designs. Temperature and humidity significantly increased (p < 0.05) during each respirator application. Significant increases in transepidermal water loss values (p < 0.05) were observed after the application of the respirators in females, which were most apparent at the nasal bridge.</p><p><strong>Conclusion: </strong>The results revealed that specific facial features affected the distribution of interface pressures and depending on the respirator design and material, changes in skin barrier function were evident. The development of respirator designs that accommodate a diverse range of face shapes and protect the end users from skin damage are required to support the long-term use of these devices.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"241-252"},"PeriodicalIF":1.3,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9343257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40682770","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":"Clinical Proof of Concept for Stabilization of Tracheostomy Tubes Using Novel DYNAtraq Device.","authors":"Mauricio Orozco-Levi,&nbsp;Carlos Reyes,&nbsp;Neikel Quintero,&nbsp;Diana Tiga-Loza,&nbsp;Mabel Reyes,&nbsp;Sandra Sanabria,&nbsp;Camilo Pizarro,&nbsp;Juan De Hoyos,&nbsp;Norma Serrano,&nbsp;Victor Castillo,&nbsp;Alba Ramírez-Sarmiento","doi":"10.2147/MDER.S366829","DOIUrl":"https://doi.org/10.2147/MDER.S366829","url":null,"abstract":"<p><strong>Introduction: </strong>Tracheostomy is one of the most common surgical strategies in intensive care units (ICU) and provides relevant clinical benefit for multiple indications. However, the complications associated with its use range from 5 to 40% according to different series. The risk of these complications could be reduced if fixation strategies and alignment of the tracheostomy tube with respect to the tracheal axis are improved.</p><p><strong>Aim: </strong>To build a functional device of technological innovation in respiratory medicine for the fixation and alignment of tracheostomy cannula (acronym DYNAtraq) and to evaluate its feasibility and safety in a pilot study in mechanically ventilated patients.</p><p><strong>Methods: </strong>Study carried out in four phases: (1) design engineering and functional prototyping of the device; (2) study of cytotoxicity and tolerance to the force of traction and push; (3) pilot study of feasibility and safety of its use in tracheostomized and mechanically ventilated patients; and (4) health workers satisfaction study.</p><p><strong>Results: </strong>The design of the innovative DYNAtraq device included, on the one hand, a connector with very little additional dead space to be inserted between the cannula and the ventilation tubes, and, on the other hand, a shaft with two supports for adhesion to the skin of the thorax with very high tolerance (several kilograms) to pull and push. In patients, the device corrected the malpositioned tracheostomy tubes for the latero-lateral (p < 0.001) and cephalo-caudal angles (p < 0.001). Its effect was maintained throughout the follow-up time (p < 0.001). The use of DYNAtraq did not induce serious adverse events and showed a 70% protective effect for complications (RR = 0.3, p < 0.001) in patients.</p><p><strong>Conclusion: </strong>DYNAtraq is a new device for respiratory medicine that allows the stabilization, alignment and fixation of tracheostomy tubes in mechanically ventilated patients. Its use provides additional benefits to traditional forms of support as it corrects misalignment and increases tolerance to habitual or forced movements. DYNAtraq is a safe element and can reduce the complications of tracheostomy tubes.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"215-227"},"PeriodicalIF":1.3,"publicationDate":"2022-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/bf/46/mder-15-215.PMC9289456.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40540086","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}