BACKGROUND AND PURPOSE:Early ischemic changes on pretreatment NCCT quantified using ASPECTS have been demonstrated to predict outcomes after IAT. We sought to determine the interobserver reliability of ASPECTS for patients with AIS with PAO and to determine whether pretreatment ASPECTS dichotomized at 7 would demonstrate at least substantial agreement.
Objective:To determine the effects of parenteral omega 3 fatty acids (10% fatty acids) on respiratory parameters and outcome in ventilated patients with acute lung injury.Measurements and Main Results:Patients were randomized into two groups – one receiving standard isonitrogenous isocaloric enteral diet and the second receiving standard diet supplemented with parenteral omega 3 fatty acids (Omegaven, Fresenius Kabi) for 14 days. Patients demographics, APACHE IV, Nutritional assessment and admission category was noted at the time of admission. No significant difference was found in nutritional variables (BMI, Albumin). Compared with baseline PaO2/FiO2 ratio (control vs. drug group: 199 ± 124 vs. 145 ± 100; P = 0.06), by days 4, 7, and 14, patients receiving the drug did not show a significant improvement in oxygenation (PaO2/FiO2: 151.83 ± 80.19 vs. 177.19 ± 94.05; P = 0.26, 145.20 ± 109.5 vs. 159.48 ± 109.89; P = 0.61 and 95.97 ± 141.72 vs. 128.97 ± 140.35; P = 0.36). However, the change in oxygenation from baseline to day 14 was significantly better in the intervention as compared to control group (145/129 vs. 199/95; P < 0.0004). There was no significant difference in the length of ventilation (LOV) and length of ICU stay (LOS). There was no difference in survival at 28 days. Also, there was no significant difference in the length of ventilation and ICU stay in the survivors group as compared to the non survivors group.Conclusions:In ventilated patients with acute respiratory distress syndrome, intravenous Omega 3 fatty acids alone do not improve ventilation, length of ICU stay, or survival.
Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices’ safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration’s public workshop, “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine” and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases.
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