McLaughlin Diane C, Schaller Michael P, Bösel Julian, Chmayssani Mohamad
Lyerly Neurosurgery, Baptist Medical Group, Jacksonville, FL.
Department of Critical Care, Mayo Clinic Campus in Florida, Jacksonville, FL.
Crit Care Explor. 2025 Mar 26;7(4):e1227. doi: 10.1097/CCE.0000000000001227. eCollection 2025 Apr 1.
Percutaneous tracheostomy (PT) is generally considered a safe procedure, but complications such as malpositioning, bleeding, and tracheal ring rupture remain concerns, particularly during initial needle insertion. This study investigates the feasibility, ease of use, and safety of a novel device and technique for bedside PT, named the Illuminated Tracheal Alignment Guide (iTAG).
An interventional pilot study evaluated the feasibility and safety of the iTAG device and method. The study was approved by our local institutional review board and a Food and Drug Administration waiver was granted for use of our device. Patients in a neurocritical care unit requiring tracheostomy were screened and consented for inclusion. Exclusion criteria included significant vascular overlap and specific ventilator settings. The iTAG method involves a laser light source and a needle guide with a hard stop, used in conjunction with standard PT equipment. Data on demographics, procedure details, and early complications were collected and compared with historical control data from patients who underwent standard tracheostomy (ST).
From January 2023 to July 2024, 30 patients underwent PT using the iTAG device. The mean time from intubation to tracheostomy was 15.53 days, with a mean ICU length of stay of 31.14 days. The iTAG group experienced significantly fewer early complications compared with the historical ST control group, including reduced hemorrhage, and there were no instances of tracheal ring fracture, posterior wall injury, or pneumothorax. The iTAG method allowed for safe PT in all patients.
The iTAG device enhances the safety and efficacy of PT by providing precise visualization and limiting needle penetration, reducing early complications. Its use expands patient candidacy for PT and offers a valuable tool for training less-experienced practitioners. Further research with larger cohorts and randomized controlled trials is needed to confirm these findings and establish the iTAG method as a standard of care for PT.
经皮气管切开术（PT）通常被认为是一种安全的手术，但诸如位置不当、出血和气管环破裂等并发症仍然令人担忧，尤其是在最初插入针头期间。本研究调查了一种名为照明气管对准导向器（iTAG）的新型床边PT设备和技术的可行性、易用性和安全性。
一项介入性试点研究评估了iTAG设备和方法的可行性和安全性。该研究获得了我们当地机构审查委员会的批准，并获得了美国食品药品监督管理局的豁免，允许使用我们的设备。对神经重症监护病房中需要气管切开术的患者进行筛选并同意纳入研究。排除标准包括明显的血管重叠和特定的呼吸机设置。iTAG方法涉及一个激光光源和一个带有硬限位器的针导向器，与标准PT设备一起使用。收集了人口统计学、手术细节和早期并发症的数据，并与接受标准气管切开术（ST）的患者的历史对照数据进行了比较。
从2023年1月到2024年7月，30例患者使用iTAG设备进行了PT。从插管到气管切开术的平均时间为15.53天，平均ICU住院时间为31.14天。与历史ST对照组相比，iTAG组早期并发症明显减少，包括出血减少，且没有气管环骨折、后壁损伤或气胸的病例。iTAG方法在所有患者中都实现了安全的PT。
iTAG设备通过提供精确的可视化和限制针头穿透，提高了PT的安全性和有效性，减少了早期并发症。它的使用扩大了PT的患者候选范围，并为培训经验不足的从业者提供了一个有价值的工具。需要进行更大规模队列研究和随机对照试验的进一步研究，以证实这些发现，并将iTAG方法确立为PT的护理标准。
