13 research outputs found

    Development and Validation of a 3-Dimensional Flexible Laryngoscopy Training Simulator

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    The objective of this study was to validate the use of a 3-Dimensional Flexible Laryngoscopy Training Simulator. This is a simulation device development and validation study. Anonymized CT scan data from a head/neck CT of a patient with normal anatomy was imported and a head/neck digital model was created. A 3D simulation model was printed using a stiff (Stratasys Vero) and flexible (Stratasys Agilus) material combination with a ShoreA hardness value of 60. Novices and experts were instructed and provided 5 trials to pass the laryngoscope. The videos of the first and the last trial were recorded and evaluated by three different evaluators. Performances were measured by the amount of time spent and precision of the task. Repeated measures of ANOVA and generalized linear model with binomial proportion was used were utilized to analyze the data. The post training scores were statistically significantly higher than pre training scores (Mean: 15.57 vs. 13.01, p  <0.0001) controlling for trainee experience. The time taken to complete a successful pass post training was statistically significantly lesser than pre training (Mean: 62.55 secs vs. 36.36 secs, p-value = 0.0007) controlling for individual’s experience. The odds of becoming skilled at the task was 4 times higher post training in comparison to pre training, controlling for individual’s experience (OR: 4.05, p-value: 0.0026). The 3-Dimensional Flexible Laryngoscopy Training Simulator is a valid trainer for both novice and experienced individuals. The simulator can improve technical skill performance and is critical for medical training

    Development and Validation of a 3-Dimensional Flexible Laryngoscopy Training Simulator

    No full text
    The objective of this study was to validate the use of a 3-Dimensional Flexible Laryngoscopy Training Simulator. This is a simulation device development and validation study. Anonymized CT scan data from a head/neck CT of a patient with normal anatomy was imported and a head/neck digital model was created. A 3D simulation model was printed using a stiff (Stratasys Vero) and flexible (Stratasys Agilus) material combination with a ShoreA hardness value of 60. Novices and experts were instructed and provided 5 trials to pass the laryngoscope. The videos of the first and the last trial were recorded and evaluated by three different evaluators. Performances were measured by the amount of time spent and precision of the task. Repeated measures of ANOVA and generalized linear model with binomial proportion was used were utilized to analyze the data. The post training scores were statistically significantly higher than pre training scores (Mean: 15.57 vs. 13.01, p  <0.0001) controlling for trainee experience. The time taken to complete a successful pass post training was statistically significantly lesser than pre training (Mean: 62.55 secs vs. 36.36 secs, p-value = 0.0007) controlling for individual’s experience. The odds of becoming skilled at the task was 4 times higher post training in comparison to pre training, controlling for individual’s experience (OR: 4.05, p-value: 0.0026). The 3-Dimensional Flexible Laryngoscopy Training Simulator is a valid trainer for both novice and experienced individuals. The simulator can improve technical skill performance and is critical for medical training

    Development and Validation of a 3-Dimensional Flexible Laryngoscopy Training Simulator

    No full text
    The objective of this study was to validate the use of a 3-Dimensional Flexible Laryngoscopy Training Simulator. This is a simulation device development and validation study. Anonymized CT scan data from a head/neck CT of a patient with normal anatomy was imported and a head/neck digital model was created. A 3D simulation model was printed using a stiff (Stratasys Vero) and flexible (Stratasys Agilus) material combination with a ShoreA hardness value of 60. Novices and experts were instructed and provided 5 trials to pass the laryngoscope. The videos of the first and the last trial were recorded and evaluated by three different evaluators. Performances were measured by the amount of time spent and precision of the task. Repeated measures of ANOVA and generalized linear model with binomial proportion was used were utilized to analyze the data. The post training scores were statistically significantly higher than pre training scores (Mean: 15.57 vs. 13.01, p  <0.0001) controlling for trainee experience. The time taken to complete a successful pass post training was statistically significantly lesser than pre training (Mean: 62.55 secs vs. 36.36 secs, p-value = 0.0007) controlling for individual’s experience. The odds of becoming skilled at the task was 4 times higher post training in comparison to pre training, controlling for individual’s experience (OR: 4.05, p-value: 0.0026). The 3-Dimensional Flexible Laryngoscopy Training Simulator is a valid trainer for both novice and experienced individuals. The simulator can improve technical skill performance and is critical for medical training

    ANG1005, a brain penetrating peptide-drug conjugate, shows activity in patients with breast cancer with leptomeningeal carcinomatosis and recurrent brain metastases.

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    PURPOSE: ANG1005, a novel taxane derivative, consists of 3 paclitaxel molecules covalently linked to Angiopep-2, designed to cross the blood-brain and blood-cerebrospinal barriers and to penetrate malignant cells via LRP1 transport system. Preclinical and clinical evidence of efficacy with ANG1005 has been previously shown. EXPERIMENTAL DESIGN: A multi-center, open-label phase 2 study in adult patients with measurable recurrent brain metastases from breast cancer (BCBM), with or without leptomeningeal carcinomatosis (LC) was conducted (n=72 BCBM; n=28 LC subset). ANG1005 was administered IV at 600 mg/m RESULTS: Median age was 47.5 years. Safety profile was similar to that of paclitaxel with myelosuppression as the predominating toxicity. Average number of prior CNS directed therapies was 2.6 and 94% of the patients had prior taxane treatment. Patient benefit (stable disease or better) was seen in 77% (intracranial) and 86% (extracranial) of the evaluable patients, with iORR of 15% (investigator) or 8% (independent radiology review). In the LC subset, 79% of the patients had intracranial disease control and estimated median overall survival of 8.0 months (95% CI 5.4 - 9.4). CONCLUSIONS: Even though the study pre-set rule for iORR per IRF was not met in this heavily pretreated population, a notable CNS and systemic treatment effect was seen in all patients, particularly in LC patients, including symptom improvement and prolonged overall survival compared to historical control
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