Medical Devices-Evidence and Research最新文献

Background: Bioimpedance measurement is a noninvasive diagnostic method that enables the assessment of the condition of internal organs and their activity by recording changes in impedance of the examined body area. One of the bioimpedance techniques that allows the evaluation of cardiac mechanical activity, including the estimation of stroke volume, is impedance cardiography (ICG).

Purpose: The aim of this project was to create a computer program written in widespread Java, a versatile language, valued for its reliability, scalability, and built-in features that optimize application performance. The application dedicated to mobile devices, written using the Android Studio environment, enables visualization of ICG signals simultaneously with one channel of electrocardiographic signal (ECG) and allows the preliminary analysis of basic hemodynamic parameters.

Methods: The signal analysis included determination of heart rate (HR), stroke volume (SV), cardiac output (CO), and left ventricular ejection time (LVET).

Discussion and conclusions: The program allows the user the quick visual check of the recorded signal quality, browse the traces and manually select the characteristic points on the ECG and ICG waveforms, which are then used to calculate the ICG-derived cardiac parameters. It may be used to visualize ECG and ICG signals by anyone, who could enter ICG data formatted in three text columns where each row reflects a sample of ECG, first derivative of ICG signal (dz/dt) and basic impedance (Z0).

Purpose: Progress in the design of total hip prostheses has enhanced the long-term results of total hip arthroplasty. However, recent clinical failures have raised concerns regarding the long-term performance of taper connections. Issues at the taper connection of the femoral head can lead to implant failure and revision surgery. There is scarcity of published studies on the wear performance of contemporary femoral head taper connections in carefully controlled laboratory tests. This work aims to help remedy this shortcoming.

Methods: The study comprised dynamic load frame tests and multidirectional hip joint simulator tests for two contemporary prosthesis designs with titanium alloy femoral stems and CoCr and zirconia toughened alumina (ZTA) femoral heads of 36 mm diameter and medium neck length against vitamin E stabilized, highly cross-linked polyethylene liners (n = 3). Worn surfaces were analyzed by optical and scanning electron microscopy (SEM).

Results: Wear was more prominent in the inferior and distal parts of the CoCr head tapers, and these regions aligned with those of the trunnions that showed most wear. Wear marks on CoCr heads were relatively mild, indicative of fretting due to micromotion. Material displacement occurred locally without dislodged debris. ZTA heads mainly showed titanium transfer by adhesive wear. ZTA femoral heads outperformed CoCr heads regarding wear resistance and surface stability. The 12/14 tapers showed more pronounced wear and surface modifications compared with Type 1 tapers. EDX analysis confirmed the absence of adhesion between CoCr and Ti alloy, and increased oxygen percentage on worn regions.

Conclusion: The wear marks were mild. No serious damage was observed. The wear behavior of the taper connections appeared satisfactory, and not a cause for concern in the short term.

Purpose: The blow-by method using a pediatric non-rebreathing mask (PNRM) is commonly employed to maintain oxygenation during transport of pediatric patients after general anesthesia. This study aimed to evaluate the performance of the blow-by method using a PNRM with an oxygen flow rate of 10 liters per minute (LPM) during simulated transport of pediatric patients.

Patients and methods: This laboratory study was simulated along a 32-meter corridor from the pediatric operating room to the post-anesthesia care unit at Srinagarind Hospital. A pediatric mannequin was positioned laterally on a transport trolley. A PNRM delivering oxygen at 10 LPM was placed at distances of 0, 5, and 10 cm from the mannequin's nose. The fraction of inspired oxygen (FiO₂) at the mannequin's nose was measured every 2 meters along the corridor. Each distance condition was tested 10 times. The primary outcome was whether the blow-by method could maintain FiO₂ above 40% at all measurement points during simulated patient transport.

Results: Oxygen delivery was adequate only when the PNRM was placed at 0 cm from the nose, with a mean FiO₂ of 86.9 ± 0.3%, In contrast the mean FiO₂ values at 5 and 10 cm was 28.5 ± 0.3%, and 24.1 ± 0.1%, respectively. The mean FiO₂ difference between 0 and 5 cm was 58.4% (95% CI: 56.8-60.1; p < 0.001), and between 0 and 10 cm was 62.8% (95% CI: 61.5-64.1; p < 0.001).

Conclusion: The blow-by method using PNRM positioned at 0 cm from pediatric mannequin's nose provided adequate oxygenation throughout transport. Clinically, therefore, maintaining a close PNRM position is essential.

The Balance Tracking System (BTrackS) is a medical device developed over a decade ago as a low-cost and portable solution to expensive and cumbersome force plate balance measurement instruments. Consisting of the BTrackS Balance Plate and Assess Balance software, this technology is now employed worldwide by thousands of practitioners. An evidence base of more than 80 research studies had been published using BTrackS technology. This includes the positive establishment of device/protocol validity and reliability, normative data, as well as translational work comparing balance amongst a variety of sample populations. In addition, BTrackS has been successfully used for both evaluating the efficacy of balance interventions, manipulations, and devices, including several BTrackS bio-feedback-based training protocols themselves. The present narrative review compiles and summarizes this research in single source as a repository for BTrackS practitioners, and as a guide for informing future research efforts.

Purpose: The objective of this study was to evaluate and compare the effectiveness of a narrow-profile, small-diameter reload to a powered vascular stapler when used during VATs lobectomy.

Patients and methods: This was a retrospective, observational cohort study comparing outcomes after VATs lobectomy procedures in which either the Echelon Flex™ powered vascular stapler (PVS) or a Signia™ small-diameter reload (SDR) was used to transect pulmonary vasculature. Data from adult patients (≥18 years of age) who had lung cancer and underwent elective, primary VATs lobectomy in the 3 years between 2021 and 2023 were extracted from the PINC AI healthcare database. Two patient groups (PVS vs SDR) were propensity-score matched using a 1:1 nearest neighbor matching scheme with a caliper of 0.2 to adjust the baseline patient characteristic imbalance. Two sensitivity analyses were performed using multivariable regression models and propensity score inverse probability weighting.

Results: Of 558 (34.1% SDR and 65.9% PVS) eligible inpatient cases, 68.5% age ≥65, 58.2% were female, 59.0% were married, 79.8% White, 68.5% were Medicare, 73.5% had comorbidity ≥3. One hundred and ninety pairs were matched. The incidence rate of blood transfusion was significantly higher in the PVS group than in the SDR group (PVS vs SDR: 6.4% vs 0.5% for matched pairs, difference: 5.8%, 95% confidence interval (CI) 2.2%-9.5%, p = 0.002). The incidence rate of bleeding was not significantly different between the groups and no conversions were observed. Intensive care unit visits and length of stay were higher in the PVS group. Sensitivity analyses results were consistent with these findings.

Conclusion: The narrow-profile SDR was an effective and beneficial tool for division and ligation during VATs lobectomy and is associated with fewer blood transfusions compared to PVS.

Introduction: Early diagnosis of eye diseases improves outcomes and reduces blindness. However, diagnostic capacity in resource-poor settings is limited by a shortage of trained and equipped healthcare professionals. The Arclight device is a user-friendly, cost-effective diagnostic tool for both anterior and posterior segment eye diseases that requires minimal training. Studies have shown it to be effective for assessing the fundal reflex and performing fundoscopy; however, its accuracy and acceptability for anterior segment eye disease are still unknown.

Methods: This was a cross-sectional study carried out at Mulago National Super Specialised Hospital, where 21 ophthalmic clinical officers (OCOs) were recruited from surrounding districts. Each participant evaluated eleven patients with anterior segment pathologies and one normal case using the Arclight loupe and a handheld Slit Lamp. The diagnosis and the proportion of correctly identified conditions were recorded. Focus group discussions were held to assess the acceptability of using the devices. Discussions were transcribed verbatim and analysed using latent and manifest content analysis.

Results: Of the 21 participants, 13 (61.9%) were female, with a median age of 39 (IQR: 33-49), and had practiced for 6 to 10 years, representing 76.2%. The majority of conditions were correctly identified by both the Arclight (71.2%) and handheld slit lamp (72.3%). Pterygium was the most accurately diagnosed condition (100%) with the Arclight. Based on themes from Sekhon's framework and the Technology Acceptance Model, the Arclight device was found to be highly acceptable and easy for OCOs to use.

Conclusion: The performance of the OCOs in diagnosing anterior segment diseases with the Arclight is comparable to that of a handheld Slit lamp. It was also found to be an acceptable device for diagnostic purposes. In conclusion, the Arclight device is a suitable, low-cost alternative to the handheld Slit Lamp, especially in resource-limited settings.

Background: This study evaluates the association between the type of topical haemostatic agents used during surgery-categorized as active, passive, or a combination of both-and their relationship with intraoperative blood loss and bleeding-related postoperative outcomes.

Methods: A retrospective analysis was conducted at Cooper Health System, Camden, New Jersey, US, using patient records to compare the clinical performance of three haemostatic strategies: active agents, passive agents, and a combined approach.

Results: A total of 149 patients were included in the analysis: 51 treated with passive agents, 51 with active agents, and 47 with both. The mean age at admission was 55.9 years (SD ±16.3). General surgery was the most frequently represented specialty (24.8%), followed by spine (22.1%), neurosurgery (16.8%), and solid organ procedures (16.1%). The combination group showed the highest estimated blood loss (EBL) at 521.3 mL (SD ±1456.83; 95% CI: 93.5-949.0), compared to 390.7 mL (SD ±1004.81; CI: 108.1-673.3) in the active group and 301.5 mL (SD ±295.78; CI: 218.3-384.7) in the passive group. However, ANCOVA results showed no statistically significant difference in adjusted mean EBL between groups (p = 0.309). Notably, patients in the combination group experienced longer operative times, extended ICU stays, and higher mortality.

Conclusion: Numerical trends suggest greater bleeding and more complex postoperative courses in patients treated with the combination of active and passive haemostats. The use of standardized, validated measures of intraoperative bleeding, paired with a strategic approach that anticipates and manages bleeding complications, may support improved clinical outcomes.

Introduction: Pain due to injection and fear of needles is documented barriers to vaccination in children. Needle-Free Injection System ie N-FIS^®, is an innovative delivery solution that addresses these limitations. To demonstrate its performance, study was conducted to compare immunogenicity and safety of the MMR vaccine when administered by N-FIS, to that administered using needle-syringe and needle.

Methodology: This was a prospective, randomized, parallel group study (January-September 2024). Eligible participants 9-12 months of age were administered MMR vaccine 0.5 mL, subcutaneously using either N-FIS^® or syringe. Immunogenicity and safety were assessed before and 28 days post vaccination.

Results: A total of 60 infants with mean age of 10.5 months were enrolled in the study. At 28 day post dose 1 there was a significant and comparable rise in the MMR GMTs between the two groups. Similarly, at 28 day post vaccination, there was a significant rise in the proportions of seropositive subjects and the rates were comparable between the two groups (Measles: 100% vs 83%, p = 0.046; Mumps: 96.1% vs 95.8%, p = 0.999, Rubella: 92.3% vs 100%, p = 0.491). N-FIS was well tolerated and significantly lower number of subjects experienced pain (12% with N-FIS vs 33% with syringe). No serious or severe adverse events were reported.

Conclusion: Administration of MMR vaccine using N-FIS induced robust and comparable immune responses to that observed with use of Needle-syringe and was well tolerated providing an alternative to paediatrician over conventional delivery system.

Introduction: Spinal surgeries often require the manipulation of bone structures while at the same time protecting sensitive tissues. Existing surgical systems involve manual force, which has a high risk of damaging the vertebrae and instruments interfere with the visibility between the vertebrae, which complicates work. The OrtoWell^® Distractor System, an intra-surgical hydraulic tool for vertebrae separation, offers incremental and stable force control and better visibility during distraction procedures in spinal surgeries. This study aims to fill the gap of still pending clinical trials using the device, by evaluating performance and safety of it across lumbar and thoracic surgeries.

Materials and methods: This study is a prospective, single-arm, multi-center observational study and was conducted between April 2018 and April 2023 at 3 German sites in patients undergoing anterior or lateral spinal surgery requiring vertebral separation. The device's safety and usability were assessed through surgeon-completed questionnaires on the device and its subcomponents, clinical outcomes and cardiovascular assessments. Assessments were conducted at four time points, at baseline, time of the index procedure, discharge and at a 30-day follow-up.

Results: 31 patients (13 males, mean age 62.33) were included. Single and multi-level treatments were performed using different accesses. The device facilitated spinal surgeries without any complications or device-related adverse events. Usability, stability and force control were evaluated as uniformly positive and all procedures proceeded as planned. Mean applied pressure was 147.69±29.48 bar. There were no major delays in surgical time and a mean blood loss of 215.17±113.57 cc. Cardiovascular parameters remained stable, with no significant changes between baseline and follow-up. Hospital stays averaged 16.39±10.25 days. Surgeons unanimously reported that the distractor simplified surgery.

Discussion and conclusions: The investigated device demonstrated high safety and performance, enabling precise force control and simplifying spinal surgeries. These findings suggest that hydraulic distractors could enhance surgical outcomes by improving intraoperative control and reducing procedural challenges.

Trial registration: Registered at ClinicalTrials.gov (NCT03501810, 12 Mar 2018).

Background: Micropulse transscleral diode cyclophotocoagulation (MP-TSCPC) has been developed as an alternative and safer approach to cyclodestructive procedures. While MP-TSCPC has an improved safety profile, reported complications of this procedure, though uncommon, include anterior chamber inflammation, mydriasis, hypotony, macular edema, corneal edema, phthisis bulbi, vitreous hemorrhage (VH), and conjunctival hemorrhage.

Case presentation: We report a case of a 76-year-old male who underwent uneventful MP-TSCPC for the left eye due to moderate primary-open angle glaucoma. A few days following the procedure, dense VH developed without hyphema or suprachoroidal hemorrhage. The VH persisted despite observation, and pars plana vitrectomy was performed, the patient recovered quickly, and achieved a visual acuity of 6/12 with an intraocular pressure of 10 mmHg.

Conclusion: MP-TSCPC is considered a safe and effective procedure in glaucoma management. However, the treating ophthalmologist should always be aware of rare but potentially serious complications. In our case report, we report a case of dense VH without hyphema or suprachoroidal hemorrhage following MP-TSCPC.