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Proposed Solution
Our project aims to develop an instantaneous, non-invasive, and user-friendly electrical surface stimulation system to rapidly break laryngospasms during surgeries, contributing to safer operations.
To fulfill this aim, our objectives include:
Safety and Performance: We strive to create a device that operates safely without causing excessive harm or discomfort to the patient. We will assess safety and effectiveness using bench tests, computational simulations, and animal studies during preclinical evaluation. Further, we will monitor patient comfort, adverse effects, and vital signs during clinical evaluations.
Optimal Parameters: By conducting a series of trials, we aim to identify the ideal device parameters to deliver the most effective stimulation.
Reliability and Non-Invasiveness: Our goal is to design a system that applies a safe level of stimulation, functioning reliably without overstimulation or unnecessary discomfort to the patient.
Autonomy: We seek to develop a rapidly deployable device that can be immediately implemented when a laryngospasm occurs.
Our project must also navigate several constraints including scheduling and time limits, ensuring safety and minimal side effects, arranging animal models for testing, and completing thorough pre-testing safety evaluations. We intend to mitigate these constraints through efficient time management, prioritizing safety, adapting to scheduling changes, and conducting comprehensive pre-testing safety checks.
Design Solution
Our project is committed to developing an effective and user-friendly method to alleviate laryngospasms that occur during surgical procedures. To achieve this, we underwent a meticulous process of data collection and analysis, focusing on various electrical stimulation parameters. The main components of our solution are:
Data Collection:
We devised a comprehensive set of parameters for testing, using a Transcutaneous Electrical Nerve Stimulation device (BioStim NMS2), a laryngoscope, and electrode leads. Ensuring utmost safety, our testing sessions were supervised by Otolaryngologist-Head and Neck Surgeon Andrew Vahabzadeh-Hagh. We experimented with diverse electrode orientations and placements around the trachea and larynx, along with varying electrode sizes. Post-testing, we gathered video recordings for further examination.
Data Analysis:
To interpret the results, we measured vocal cord angles of adduction at three distinct points during each test to ascertain measurement reliability. All tests were repeated under identical conditions for standardization and conducted both with and without stimulation to compare the effectiveness of the parameters.
Adaptations to Original Design:
Our journey to this point hasn't been without adaptations. While we initially intended to perform tests on a swine model, COVID-19 related restrictions and unexpected delays in obtaining lab approvals led us to use human subjects, specifically our team members. As inducing laryngospasm in humans isn't ethically permissible, we couldn't directly observe the impact of surface stimulation on laryngospasm. Nonetheless, our research remains focused and determined to fulfill its primary goal.
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