Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety

Официальное название

NextGen Tracheostomy Toolkit: Integrating Augmented and Virtual Reality With Robotics to Improve Tracheostomy Care

Обзор

The goal of this clinical trial is to test the NextGen Tracheostomy Toolkit in people who have a tracheostomy. The main questions it aims to answer are: * What is the number of atraumatic tracheostomy suctionings before and after the use of automated robotic suctioning device divided by the total number of tracheostomy suctionings across arms experimental group 1 vs. control group? * What is the number of atraumatic tracheostomy suctionings before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy suctionings across arms experimental group 3 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of mixed reality tracheostomy tube change device divided by the total number of tracheostomy tube changes across arms experimental group 2 vs. control group? * What is the number of successful first-time tracheostomy tube change attempts before and after the use of Nextgen Tracheostomy Toolkit divided by the total number of tracheostomy tube changes across arms experimental group 3 vs. control group? Participants will be randomly divided into 4 groups and assigned different interventions. 1. Experimental group 1 will receive suctionings using automated robotic suctioning device. 2. Experimental group 2 will receive tracheostomy tube changes using mixed reality tracheostomy tube changing system. 3. Experimental group 3 will receive Nextgen Tracheostomy Toolkit that includes suctionings using automated robotic suctioning device and tracheostomy tube changes using mixed reality tracheostomy tube changing system. 4. Control group will receive usual tracheostomy care Researchers will compare the four groups to see the effect of Nextgen tracheostomy toolkit and its components on the number of atraumatic tracheostomy suctionings and number of successful first-time tracheostomy tube changes.

Вмешательства

• Устройство NextGen automated tracheostomy suctioning device
  Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctionings using an automated robotic suctioning device.
• Устройство NextGen mixed-reality tracheostomy tube change system
  Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy tube changes using the mixed reality tracheostomy tube change system.
• Устройство NextGen Tracheostomy Toolkit
  Providers will be trained on tracheostomy care using multiplayer virtual reality educational modules and participants will receive tracheostomy suctioning using the robotic suctioning device; and tracheostomy tube changes using the mixed reality tracheostomy tube change system.

Первичные конечные точки

• Number of Successful first-time tracheostomy tube changes [Срок оценки: An average of 6 weeks]
• Percent of Successful Atraumatic suctionings [Срок оценки: An average of 6 weeks]

Вторичные конечные точки (12)

• Discomfort as assessed by a Visual Analog Pain Scale [Срок оценки: During tracheostomy suctioning]
• Discomfort as assessed by the Wong-Baker FACES Pain Rating Scale [Срок оценки: During tracheostomy suctioning]
• Occurrence of Stomal Infection [Срок оценки: At time of receiving tracheostomy up to approximately 6 weeks]
• Occurrence of airway bleeding complications [Срок оценки: During tracheostomy suctionings]
• Occurrence of Tracheostomy tube dislodgments [Срок оценки: During procedure up to 6 weeks]
• Occurrence of False tract [Срок оценки: During procedure]
• Occurrence of Airway Obstruction [Срок оценки: An average of 6 weeks]
• Occurrence of Ventilator-associated pneumonia [Срок оценки: An average of 6 weeks]
• Patient/family satisfaction [Срок оценки: Immediately after procedure]
• Patient/family acceptability [Срок оценки: Immediately after procedure]
• Equitable delivery of care as assessed by summary of demographic factors [Срок оценки: Immediately after procedure]
• Intensive care unit length of stay (LOS) [Срок оценки: An average of 6 weeks]

Критерии участия

Критерии включения

• adult patients 18 years or older
• those who received a tracheostomy during their hospital stay
• those who were admitted to the hospital with a tracheostomy

Критерии исключения

• none

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Johns Hopkins University — Baltimore
• University of Michigan — Ann Arbor

Публикации

• Martin KA, Cole TDK, Percha CM, Asanuma N, Mattare K, Hager DN, Brenner MJ, Pandian V. Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study. Ann Am Thorac Soc. 2021 Oct;18(10):1693-1701. doi: 10.1513/AnnalsATS.202010-1282OC. PMID 33760713
• McGrath BA, Wallace S, Lynch J, Bonvento B, Coe B, Owen A, Firn M, Brenner MJ, Edwards E, Finch TL, Cameron T, Narula A, Roberson DW. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020 Jul;125(1):e119-e129. doi: 10.1016/j.bja.2020.04.064. Epub 2020 May 31. PMID 32493580
• Cherney RL, Pandian V, Ninan A, Eastman D, Barnes B, King E, Miller B, Judkins S, Smith AE 4th, Smith NM, Hanley J, Creutz E, Carlson M, Schneider KJ, Shever LL, Casper KA, Davidson PM, Brenner MJ. The Trach Trail: A Systems-Based Pathway to Improve Quality of Tracheostomy Care and Interdisciplinary Collaboration. Otolaryngol Head Neck Surg. 2020 Aug;163(2):232-243. doi: 10.1177/0194599820917427. PMID 32450771
• Brenner MJ, Pandian V, Milliren CE, Graham DA, Zaga C, Morris LL, Bedwell JR, Das P, Zhu H, Lee Y Allen J, Peltz A, Chin K, Schiff BA, Randall DM, Swords C, French D, Ward E, Sweeney JM, Warrillow SJ, Arora A, Narula A, McGrath BA, Cameron TS, Roberson DW. Global Tracheostomy Collaborative: data-driven improvements in patient safety through multidisciplinary teamwork, standardisation, education, a PMID 32456776

Идентификаторы

NCT: NCT06236542 · IRB00430139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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