Medical Devices-Evidence and Research最新文献

Purpose: The existing 2-bladed vaginal speculum has limitations and barriers to gynecologic diagnosis and treatment. This study aimed to evaluate three of these limitations (visualization of the cervix, ease of use, and relative comfort) using a newly designed vaginal speculum that was hypothesized to overcome these limitations.

Methods: This pilot prospective observational clinical study was conducted at five hospitals in Karachi, Pakistan. Six clinicians were surveyed using two questions on the visibility of the cervix and ease of use of the new vaginal speculum. A total of 100 patients were surveyed to determine the relative comfort of the new speculum.

Results: Clinicians rated the visualization of the cervix as "better" in 66% of women (p=0.0007). The newly designed vaginal speculum was reported by clinicians as "easier" to use in 57% of patients (p=0.0808). The survey results indicated that 53% of participants felt less discomfort with the new speculum (p=0.2743). There was a strong statistical correlation between clinician visualization of the cervix and ease of use (+0.8234, p < 0.0001), visualization and comfort (+0.8978, p < 0.0001), and ease of use and comfort (+0.9101, p < 0.0001).

Conclusion: This new vaginal speculum demonstrated improved cervical visualization and ease of use in a cohort of 100 Pakistani women. In addition, participants in this study reported less discomfort with the new speculum. There is a potential benefit for all gynecologic screening and treatment with this new vaginal speculum design, especially in resource-constrained countries and in certain disadvantaged populations. The newly designed speculum has been field-tested in multiple countries over the last 5 years. Further clinical studies with larger cohorts are warranted.

Objective: To assess the utility of digital biomarkers derived from a head-mounted wearable physiological vibration acceleration (phybrata) sensor to quantify age-related balance impairments, sensory reweighting, and fall risks in older populations.

Methods: Data were collected and analyzed from 516 participants aged 77.7 ± 8.0 yrs (min 51 yrs, max 98 yrs, 334 females, 182 males) in 4 residential senior living communities. Participants first completed a questionnaire that included their fall history in the past 6 months. A 2-minute standing balance test was then carried out for each participant using the phybrata sensor (1 minute with eyes open, followed by 1 minute with eyes closed). Four balance performance biomarkers were derived from the phybrata time series data: eyes open (Eo) and eyes closed (Ec) phybrata powers, average phybrata power (Eo+Ec)/2, and Ec/Eo phybrata power ratio. Sensory reweighting biomarkers were derived from phybrata acceleration spectral density (ASD) distributions. Results are compared for participants with no reported fall history (NF) and those reporting one or more falls (FR) in the previous 6 months.

Results: All four phybrata balance performance biomarkers show significantly higher values for FR participants vs NF participants. As a fall risk biomarker, Ec phybrata power was found to have the strongest statistical correlation with the reported retrospective incidence of falls within the previous 6 months. The Ec phybrata biomarker also showed the strongest statistical difference between F and M participants. Phybrata sensory reweighting biomarkers quantify age-related impairments and sensory reweighting across sensory inputs (visual, vestibular, proprioceptive), central nervous system (CNS) processing, and neuromotor control (vestibulocollic reflex), revealing progressive reductions in visual and vestibular balance regulation and vestibulocollic head stabilization that are offset by an increasing reliance on proprioceptive balance control.

Conclusion: Phybrata digital biomarkers enable rapid objective assessment of progressive age-related balance impairments, sensory reweighting, and fall risks in older populations.

Purpose: Measuring maximal airway pressure is an essential part of the assessment of respiratory functions. Portable handheld devices have made clinical measurements more available, but reliable and user-friendly devices for non-clinical use remain rare. This study sought to determine the validity and short-term repeatability of measurements of dynamic maximal inspiratory pressure (dMIP) and dynamic maximal expiratory pressure (dMEP) by using a novel self-administered respiratory health meter (WellO2-RHM) in asymptomatic young adults.

Patients and methods: dMIP and dMEP were measured with WellO2-RHM in asymptomatic adult volunteers (n=26, 15 male and 11 female, age 26-41 years). These values were compared with quasi-static maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) obtained from the same volunteers using another respiratory manometer (MicroRPM). The measurements of dMIP and dMEP with WellO2-RHM were repeated in the same individuals at an interval of one week for assessment of their short-term repeatability.

Results: The Pearson correlation coefficients of dMIP and dMEP values with MIP and MEP values were high (r=0.840, p<0.001; r=0.849, p<0.001, respectively). The dMIP and dMEP values were consistently lower than the quasi-static MIP and MEP values in the same individuals. The short-term repeatability of the dMIP and dMEP in one week interval proved to be moderately good in terms of the coefficient of variation (CV), the intraclass correlation coefficient (ICC), the standard error of measurement (SEm) and minimal detectable change (MDC) (10.0%, 0.825, p<0.001, 7 cmH2O and 20 cmH2O and 9.1%, 0.895, p<0.001, 12 cmH2O and 34 cmH2O, respectively).

Conclusion: The results indicate that the WellO2-RHM is a valid and repeatable method for the assessment of dMIP and dMEP in asymptomatic young adults, but the absolute values are lower than those obtained with devices measuring quasi-static MIP and MEP. The findings suggest that WellO2-RHM can be used for self-monitoring of the effects of respiratory muscle training in healthy young adults.

Introduction: A novel Neuro-Bio-Electric-Stimulation device (Neubie, Neufit, Austin, Texas, USA) using Direct Current (DC) has been used to treat various neurological conditions (ALS, MS, peripheral neuropathy, chronic pain) and functional limitations such as limited range of motion. One method, called the Master Reset Protocol, is thought to stimulate the vagus nerve system, impacting heart rate, digestion and other vital systems.

Purpose: We used the Master Reset Protocol on a subject experiencing paroxysmal Atrial Fibrillation (AFib) to assess whether this treatment might be effective in reversing a cardiac arrhythmia.

Subject and methods: A single subject is reported in this Case Report. The subject is a 62-year-old healthy, athletic male, 6'2″ tall, 165 lbs. with a good diet and is not obese nor has other exacerbating underlying conditions related to heart disease. The subject experiences arrhythmia approximately 1-2 times per month lasting generally 3 or more days per the subject. The Master Reset Method was initiated within 12 hours of arrhythmia onset, and arrhythmia before and after treatment was confirmed through subject observation and confirmed with pulse readings. A total of ten treatments were conducted over 7 months.

Results: Reversal of arrhythmia was confirmed during or within 24 hours of treatment with DC application for all 10 treatments (100%). Two of the more severe cases of AFib required two treatments on the same day with confirmed reversal of AFib.

Conclusion: Treatment with Direct Current suggests a good correlation with reversal of arrhythmia. Further studies are planned to determine if similar, regular, treatments can be effective in preventing arrhythmia.

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.