Medical Devices-Evidence and Research最新文献

The Sleeve-Type Endotracheal Tube (STET) is an innovative airway management device designed to address the limitations associated with traditional double-lumen tubes (DLTs) and bronchial blockers (BBs). Utilizing a modular structure comprising an outer sheath tube, inner sheath tube, and blocking tube, the STET offers increased flexibility in one-lung ventilation (OLV) and airway clearance, thereby reducing airway trauma and improving ventilation efficiency. Its dual-cuff system ensures stable positioning, while its versatile design accommodates diverse patient populations, including pediatric patients and those with difficult airway anatomy. This review explores the structural characteristics, manufacturing processes, clinical advantages, potential limitations, and practical applications of the STET. After multiple rounds of structural optimization, the STET design has successfully advanced into pilot production. Preliminary validation results from small-scale manufacturing and functional testing demonstrate promising structural stability, operational flexibility, and safety performance. The STET represents a significant advancement in airway management, holding substantial potential to improve patient outcomes and transform clinical practice in thoracic surgery and critical care anesthesiology.

Background: An infusion pump designed to deliver a specific volume at a predetermined rate is unable to detect extravasation and may continue infusion despite increased tissue resistance caused by extravasation. Consequently, it is recommended that vesicant drugs, such as chemotherapeutic agents, be administered via gravity infusion to reduce the risk of tissue damage. However, intravenous flow regulators used for gravity infusion have limitations because the infusion rate is influenced by the height, venous pressure, and viscosity of the fluid, which can change with temperature. In this study, we measured the accuracy of Accudrip, a new gravity-based automatic infusion control device designed to correct fluctuating infusion rates.

Methods: In 59 cancer patients administered with anticancer drugs, the actual administration rate using Accudrip under various administration conditions and the theoretical administration rate were measured and analyzed 100 times.

Results: Comparing the theoretical and actual administration rates using Accudrip confirmed that it can be injected with an average error rate of 4.75%, which clinically demonstrated sufficient accuracy for fluid administration.

Conclusion: The gravity-based automatic infusion system showed high accuracy consistent with the theoretical rate of administration even under multiple infusion conditions of cancer patients with chemoport. This system (Accudrip) will greatly contribute to accurate drug administration and minimization of adverse events in real-world hospital settings.

Purpose: The Subsalve helmet continuous positive airway pressure (CPAP) circuit is a low-cost, easy to implement non-invasive ventilation option for treatment of acute respiratory failure. The circuit is simple to set up and operate, and is designed to be used with any commonly available continuous positive airway pressure device.

Model materials and methods: Simulation of an acute respiratory distress syndrome (ARDS) patient allows optimization of treatment parameters without risk. The boundaries of safe and effective helmet CPAP treatment were measured in the TestChest^® lung simulator with AQAI SIS software. The capabilities of the TestChest allow for representation of complex breathing patterns, simulation of muscular fatigue, and the ability to model patients with worsening ARDS. Treatment settings were tested by varying CPAP pressure and oxygen flow rate in a simulated ARDS patient.

Results: Moderate CPAP pressure led to significant increases in SpO₂ (oxygen saturation) (10% increase at 14 cmH₂O pressure) and maintained improvements compared to the control even at the latest stage of the disease. When oxygen was introduced, patient SpO₂ increased proportional to the oxygen flow rate. 5 liters per minute (LPM) oxygen increased patient SpO₂ by 3% in the severe ARDS model and 30 LPM oxygen increased SpO₂ by 7%. Moderate pressure led to significant increases in SpO₂ comparable to high concentrations of oxygen. CO₂ does not accumulate in the helmet as long as the minimal flow rate (60 LPM of air) is maintained during treatment.

Conclusion: Our data demonstrate that the Subsalve helmet CPAP circuit, with limited oxygen availability, is an effective treatment strategy for ARDS patients in low-resource settings. Moderate positive end expiratory pressure (PEEP) is recommended to improve blood oxygenation. Subsalve has the potential to conserve critical resources in future epidemics.

Purpose: Medication administration errors remain a persistent issue in the US healthcare system, impacting patient safety and leading to worsened outcomes, including increased mortality. Smart infusion pump interoperability with electronic health records (EHRs) has the potential to reduce intravenous (IV) medication administration errors. Smart Infusion pumps safely deliver IV medications using drug libraries that set standard dosing limits. Interoperability is their ability to wirelessly connect to EHRs to receive medications orders directly minimizing error-prone manual programming steps. However, despite being implemented over a decade ago, its real-world impact remains largely underexplored.

Methods and materials: A systematic literature review (SLR) of PubMed/Medline and Embase in November 2024 identified peer-reviewed studies assessing medication administration errors pre- and post- interoperability implementation in the inpatient hospital setting. The primary outcome measured error types directly impacted by interoperability. The secondary outcome assessed the cumulative reduction in medication administration errors.

Results: Three studies met the inclusion criteria, spanning general community hospitals, pediatric facilities, and intensive care units (ICUs). For the primary outcome of assessing medication administration errors impactable by interoperability, interoperability implementation resulted in a 15.4% to 54.8% reduction in specific medication administration errors. For the secondary outcome of all medication administration errors, the cumulative reductions in medication administration errors post-implementation ranged from 21.2% to 90.5%, with variability influenced by baseline compliance, study setting, and patient populations.

Conclusion: Smart infusion pump interoperability demonstrated consistent potential to enhance medication safety by addressing key error types and reducing cumulative errors in real-world settings. However, future research is needed to assess its impact on adverse drug events, clinician workflows, and patient outcomes. These findings underscore the importance of tailored implementation strategies to maximize interoperability's effectiveness in improving patient safety.

Purpose: To evaluate blood pressure (BP) and pulse rate (PR) measurement range and determination time of selected non-invasive blood pressure (NIBP) monitors.

Patients and methods: Seven oscillometric NIBP monitors underwent laboratory-based simulations of high and low BP and PR values to determine the outer bounds that each monitor could measure. Reliability was determined by devices' ability to detect simulation signals of chosen BP/PR values. Determination times were analyzed using One-Way ANOVA followed by post-hoc Tukey honestly significant difference.

Results: All monitors reliably reported 50-180 mmHg and 80-140 bpm simulations, except Connex which provided the narrowest ranges (only reliable at 140 and 230 bpm; 50-180 mmHg). B125 and Efficia CM120 had the widest ranges for PR (30-240 bpm and 30-220 bpm, respectively) and systolic BP (30-250 mmHg for both). Connex presented the quickest mean determination time (19.23s), followed by B125 (24.14s).

Conclusion: NIBP monitor performances varied considerably outside mid-range BP/PR and there were significant differences across determination times. NIBP devices that strike a balance between range and speed may provide the greatest clinical utility.

Purpose: To evaluate the safety, performance and user's satisfaction of OptiVantage^®, a dual head CT Contrast Delivery System, in multi-patient mode for patients requiring a contrast-enhanced CT examination.

Patients and methods: A total of 100 subjects were included in this multicentre observational clinical investigation, conducted between April 20, 2023, and October 6, 2023. The primary endpoint for safety was the rate of extravasation, and the primary endpoint for performance was the success of injection assessed by the investigator. Secondary endpoints for safety were the rates of air embolism and sepsis as well as adverse events (AE) related to the injection. Other data collected included indication, set-up time, injection parameters and user's satisfaction.

Results: The study population included 59% of women. The mean age was 63.6 ± 12.7 years (range: 18 to 83 years), with the majority of patients (55%) older than 65 years. The main indications for undergoing contrast-enhanced CT were breast cancer, colon cancer and lung cancer or nodules. The mean volume injected was 119.5 ± 14.4 mL and the injection rate ranged from 2.8 to 4.5 mL/s (mean; 3.6 ± 0.3 mL/s). No extravasation or other adverse event, including air embolism and sepsis, was reported in any of the subjects (95% CI: [0.00%, 3.62%]). All the injections (100%; 95% CI: 95.39%, 100.00%) were considered as successful for the obtention of diagnostic images. The preparation of the subject, including the setting of the patient line, took between 6 and 10 seconds in most cases (68%) and 16 to 20 seconds for 30 patients (30%). The dayset was changed for 15 subjects and in all cases, it took no more than one minute.

Conclusion: In conclusion, this study confirms the safety and performance of the OptiVantage^® Dual head in multi-use mode for contrast injection in adult patients, particularly elderly, undergoing contrast-enhanced CT.

Purpose: Pathologic hyperkeratosis due to skin thickness increase includes corn, callous, and bunion. These conditions can cause important pain and discomfort. Treatment relies on eliminating the cause of friction and/or rubbing. Moreover, hydrocolloid occlusive dressings rehydrate hard skin, leading to maceration, facilitating removal of dead skin. Our goal was to further confirm real-life clinical performance and benefits of COMPEED^® Foot Care plasters in providing pain/discomfort relief, protection and cushioning of corns, calluses and bunions.

Patients and methods: This was a non-interventional, longitudinal, multi-center investigation, conducted from July 2021 until February 2022, during which participants were enrolled in 36 community pharmacies in France. Eligible participants were ≥18 years old at enrolment, presented painful corn, callous and/or bunion on at least one foot, accepted to buy from the participating pharmacist at least one box of targeted COMPEED^® Foot Care plasters, to be used according to their instructions for use.

Results: Overall, 417 participants gave their consent to participate in the study, and analysis was performed on 391 participants: 199 with corn, 106 with callous, 87 with bunion, whose median age was, respectively, 55.0, 59.0 and 55.0 years old (overall ranging 20.0 to 94.0 years old). Among participants with either of the 3 conditions, 21.7-37.9% reported instant pain/discomfort relief upon plaster application and an increasing number of participants with corns, calluses or bunions reported pain/discomfort elimination over the 21-days follow-up period. Significant increases in pressure relief and cushioning were also observed during follow-up in all 3 conditions. Median duration of plasters was 3 days. At study end, 66.0% of participants with calluses and up to 73.0% with corns reported their condition was removed.

Conclusion: This investigation demonstrated and confirmed COMPEED^® Foot Care plasters clinical benefits in pain/discomfort and pressure relief, cushioning against rubbing/friction of corns, calluses and bunions, and adhesion to skin, in the general population.

Objective: To evaluate the efficacy and safety of the SUPRAtube innovation device in preventing ventilator associated events and fluid accumulation in the supraglottic region in patients receiving mechanical ventilation (MV) through orotracheal tubes.

Methods: Multicenter, controlled, randomized, parallel, open-label clinical trial with a 1:1 allocation ratio of MV patients compared the use of the SUPRAtube elastomeric device with standard care and aspiration techniques. A series of computer-random numbers and centralized allocation with sealed envelopes were used.

Setting: Adult patients (n=108; mean age: 63 yrs, range: 19-85) hospitalized in intensive care units of two centers, the Cardiovascular Foundation of Colombia and the International Hospital of Colombia (Santander, Colombia), were included. All patients received MV through orotracheal tubes, were hemodynamically stable, had upper airway integrity according to fiberoptic bronchoscope findings, and had basic coagulation tests within acceptable risk criteria.

Interventions: Comprehensive standard of care, including preventive strategies, medical therapy, positive pressure MV, and routine procedures for management of oropharyngeal and pulmonary secretions (humidification, patient mobilization, and airway suctioning), was compared with the standard of care plus continuous supraglottic suction with the new SUPRAtube device.

Results: The study period reached five days before extubation (media 85±7 hours). The weight of the aspirated content was 415 g (P25;P75: 396;536) in the control group and 624 g (P25;P75: 469;824) in the SUPRAtube group (p<0.001), equivalent to a mean difference of 213 g (P₂₅;P₇₅: 55;569; +50%). The device did not induce adverse events.

Conclusion: Continuous supraglottic aspiration using SUPRAtube is complementary, effective, safe, simple, and inexpensive and reduces the accumulation of oropharyngeal secretions in mechanically ventilated patients. The relevant clinical benefit in terms of preventing and improving tracheobronchitis earlier on was demonstrated by sequential fiberoptic bronchoscopy.

Registration in clinical trials: The present study is registered at clinicaltrials.gov NCT03573609.

Purpose: The present retrospective study delivers first results after the use of a pedicle based, screw and peek rod system. Emphasis was placed on the ability of the construct to prevent adjacent segment disease at an average of 5 years follow-up by maintaining a certain degree of movement in the index segment. This was evaluated via functional X Rays before and after surgery.

Patients and methods: The cohort comprised 100 patients which received decompressive surgery in one or more segments with dynamic instrumentation for stenosis of the lumbar spinal canal and degenerative spondylolisthesis. We analyzed diagnostic imagery including functional X Rays prior and after surgery as well as cohort demographics such as reoperation rate, complications and overall patient satisfaction.

Results: The average age was 68 years, at 58 months follow-up there were 43 cases of radiological adjacent segment disease. We defined a radiological ASD as an increase of the osteoarthritis on the Wiener scale and stenosis of the spinal canal on the MRI scans. In our cohort 80 patients benefited from the surgery, either being pain free or having improved symptoms at the mean follow-up with the others either requiring renewed surgery or having developed clinically significant ASD. There was no significant statistical correlation between area of spinal canal, gender and outcome.

Conclusion: In one segment constructs the system being evaluated showed no major disadvantage when compared to similar non-fusion pedicle-based techniques nor was it able to consequently prevent ASD. Under the clinical point of view there was in our opinion no marked benefit when compared against decompressive surgery and fusion as the accepted standard. Regarding the multi segment instrumentation further larger number studies are needed to reach a conclusion.

Aim: Describe the role of dedicated ultrasound in evaluating breast implants compared to breast magnetic resonance.

Materials and methods: A prospective observational study was conducted in a single center to evaluate breast implant complications in patients referred to breast magnetic resonance (MRI) scan. All patients who had breast implants submitted to MRI scan were invited to a complementary dedicated ultrasound (US) evaluation of the breast implants. The implant changes were classified following a dedicated protocol. The classifiers used to evaluate the implant include evaluation of implant surface (shell), implant internal content homogeneity, fibrous capsule, intracapsular space, pericapsular space, and axillary extension.

Results: Preliminary results included evaluating 29 consecutive patients who underwent MRI. Twenty-nine patients with 49 implants were included in the study. The US showed a superior ability to assess the internal contents of the implants, the implant surface, and the intracapsular contents. There were no significant statistical differences in evaluating macro changes such as implant location, intracapsular collection, and radio-frequency identification (RFID) presence. MRI was superior to the US in classifying the fibrous capsule type.

Conclusion: US of silicone implants can be used as an alternative to MRI to evaluate implant complications.