Clinical Evaluation of the Origin Intubation System

Обзор

There are currently two options that are utilized are artificial airways in the operating room as well in emergency medicine: the endotracheal tube and the supraglottic airway. However, with these devices, healthcare professionals often experience difficulty and/or failure in utilizing these devices during their first-pass at intubation. Additionally, military medics often forego intubation in favor of basic life support during prolonged resuscitation. This study aims to test a device, one that has been tested in over 100 cadavers, to determine if it is a viable and safer/more successful option for intubation.

Подробное описание

While previous attempts to address the challenge of airway management involve improved visualization tools (still requiring advanced anatomical knowledge), the focus of this clinical study is to evaluate the performance of the Origin Intubation System, which leverages self-deploying geometry to guide intubation. The enabling technology is vine-inspired tip-growth, in which a soft tube extends from its tip into potentially complex shapes, driven only by a low internal air pressure. This paradigm enables a novel device design that aids in intubation through semi-self-navigation, which is resilient to difficult visualization or user skill, is significantly less traumatic compared to existing methods; and fast (because it does not require the user to identify and navigate the internal anatomy).

Вмешательства

• Устройство Origin Intubation System
  This device leverages self-deploying geometry to guide intubation.

Первичные конечные точки

• Overall intubation duration [Срок оценки: Day of surgery.]

Вторичные конечные точки (6)

• First-pass intubation success [Срок оценки: Day of surgery.]
• Overall intubation success [Срок оценки: Day of surgery.]
• Adverse events [Срок оценки: From enrollment to follow-up period.]
• User assessment of intubation [Срок оценки: Day of surgery.]
• Patient assessment of intubation [Срок оценки: Day of surgery.]
• Patient airway characteristics [Срок оценки: Day of surgery.]

Критерии участия

Критерии включения

• Male or Female subjects 18 years of age or older and less than 75.
• English or Spanish Speaking.
• Undergoing elective surgery requiring endotracheal intubation.
• Use of general anesthesia.

Критерии исключения

• Patients with high aspiration risk.
• Inability to provide informed consent in English or Spanish
• Patients for whom an awake intubation is indicated and planned.
• Patients with a history of head and neck radiation.
• Pregnant patients.
• Patients with BMI >35
• ASA 4 or higher
• Patients who the investigator deems ineligible at the investigator's discretion.
• Planned post-operative intubation.
• Current incarceration.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Stanford University — Stanford

Публикации

• Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Ra PMID 30167699
• Karamchandani K, Wheelwright J, Yang AL, Westphal ND, Khanna AK, Myatra SN. Emergency Airway Management Outside the Operating Room: Current Evidence and Management Strategies. Anesth Analg. 2021 Sep 1;133(3):648-662. doi: 10.1213/ANE.0000000000005644. PMID 34153007

Идентификаторы

NCT: NCT07189182 · 80068

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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