Bösel, Julian

BACKGROUND: 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). METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

Background and Purpose— The ABC/2 score estimates intracerebral hemorrhage (ICH) volume, yet validations have been limited by small samples and inappropriate outcome measures. We determined accuracy of the ABC/2 score calculated at a specialized reading center (RC-ABC) or local site (site-ABC) versus the reference-standard computed tomography–based planimetry (CTP). Methods— In Minimally Invasive Surgery Plus Recombinant Tissue-Type Plasminogen Activator for Intracerebral Hemorrhage Evacuation-II (MISTIE-II), Clot Lysis Evaluation of Accelerated Resolution of Intraventricular Hemorrhage (CLEAR-IVH) and CLEAR-III trials. ICH volume was prospectively calculated by CTP, RC-ABC, and site-ABC. Agreement between CTP and ABC/2 was defined as an absolute difference up to 5 mL and relative difference within 20%. Determinants of ABC/2 accuracy were assessed by logistic regression. Results— In 4369 scans from 507 patients, CTP was more strongly correlated with RC-ABC ( r 2 =0.93) than with site-ABC ( r 2 =0.87). Although RC-ABC overestimated CTP-based volume on average (RC-ABC, 15.2 cm 3 ; CTP, 12.7 cm3), agreement was reasonable when categorized into mild, moderate, and severe ICH (κ=0.75; P <0.001). This was consistent with overestimation of ICH volume in 6 of 8 previous studies. Agreement with CTP was greater for RC-ABC (84% within 5 mL; 48% of scans within 20%) than for site-ABC (81% within 5 mL; 41% within 20%). RC-ABC had moderate accuracy for detecting ≥5 mL change in CTP volume between consecutive scans (sensitivity, 0.76; specificity, 0.86) and was more accurate with smaller ICH, thalamic hemorrhage, and homogeneous clots. Conclusions— ABC/2 scores at local or central sites are sufficiently accurate to categorize ICH volume and assess eligibility for the CLEAR-III and MISTIE III studies and moderately accurate for change in ICH volume. However, accuracy decreases with large, irregular, or lobar clots. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: MISTIE-II NCT00224770; CLEAR-III NCT00784134.