First Human Use of a New Robotic-Assisted Fiber Optic Sensing Navigation System for Small Peripheral Pulmonary Nodules.

BACKGROUND: We tested a new, investigational robotic-assisted bronchoscope system with a remotely controlled catheter to access small peripheral bronchi with real-time driving under live visualization and distal tip articulation of the catheter. The unique catheter remains stationary once located at the biopsy position. OBJECTIVES: The primary objectives of this study were to evaluate the safety and feasibility of a new shape-sensing robotic bronchoscope system to bronchoscopically approach and facilitate the sampling of small peripheral pulmonary nodules of 1-3 cm. Secondary objectives included evaluating procedural characteristics and early performance trends associated with the use of the new robotic bronchoscope system. METHODS: Subjects were enrolled according to study eligibility criteria at a single center. Navigation pathways were semi-automatically created using pre-procedure CT scans. Simultaneous (real-time) viewing of actual and virtual bronchi was used real time during navigation to the displayed target. An endobronchial ultrasound mini-probe was used to confirm lesion location. Flexible 19- to 23-G needles specifically designed to accommodate tight bend radii in transbronchial needle aspiration were used along with conventional biopsy tools. Enrolled subjects completed follow-up visits up to 6 months after the procedure. RESULTS: The study included 29 subjects with a mean lesion size of 12.2 ± 4.2, 12.3 ± 3.3, and 11.7 ± 4.1 mm in the axial, coronal, and sagittal planes, respectively. The CT bronchus sign was absent in 41.4% of cases. In 96.6% of cases, the target was reached, and samples were obtained. No device-related adverse events and no instances of pneumothorax or excessive bleeding were observed during the procedure. Early performance trends demonstrated an overall diagnostic yield of 79.3% and a diagnostic yield for malignancy of 88%. CONCLUSION: This new robotic-assisted bronchoscope system safely navigated to very small peripheral airways under continuous visualization, and through maintenance of a static position, it provides a unique sampling capability for the biopsy of small solitary pulmonary nodules.

A new instrument to assess physician skill at chest tube insertion: the TUBE-iCOMPT.

Currently no tool exists to assess proceduralist skill at chest tube insertion. As inadequate doctor procedural competence has repeatedly been associated with adverse events, there is a need for a tool to assess procedural competence. This study aims to develop and examine the validity of a tool to assess competency at insertion of a chest tube, using either the Seldinger technique or blunt dissection. A 5-domain 100-point assessment tool was developed inline with British Thoracic Society guidelines and international consensus­the Chest Tube Insertion Competency Test (TUBE-iCOMPT). The instrument was used to assess chest tube insertion in mannequins and live patients. 29 participants (9 novices, 14 intermediate and 6 advanced) were tested by 2 blinded expert examiners on 2 occasions. The tool's validity was examined by demonstrating: (1) stratification of participants according to expected level of expertise (analysis of variance), and (2) test-retest and intertester reliability (intraclass correlation coefficient). The intraclass correlation coefficient of repeated scores for the Seldinger technique and blunt dissection, were 0.92 and 0.91, respectively, for test-retest results, and 0.98 and 0.95, respectively, for intertester results. Clear stratification of scores according to participant experience was seen (p<0.0001). There was no significant difference between scores obtained using mannequins or live patients. This study has validated the TUBE-iCOMPT, which could now be incorporated into chest tube insertion training programmes, providing a way to document acquisition of skill, guide individualised teaching, and assist with the assessment of the adequacy of clinician training.

Novel use of pleural ultrasound can identify malignant entrapped lung prior to effusion drainage.

BACKGROUND: The presence of entrapped lung changes the appropriate management of malignant pleural effusion from pleurodesis to insertion of an indwelling pleural catheter. No methods currently exist to identify entrapped lung prior to effusion drainage. Our objectives were to develop a method to identify entrapped lung using tissue movement and deformation (strain) analysis with ultrasonography and compare it to the existing technique of pleural elastance (PEL). METHODS: Prior to drainage, 81 patients with suspected malignant pleural effusion underwent thoracic ultrasound using an echocardiogram machine. Images of the atelectatic lower lobe were acquired during breath hold, allowing motion and strain related to the cardiac impulse to be analyzed using motion mode (M mode) and speckle-tracking imaging, respectively. PEL was measured during effusion drainage. The gold-standard diagnosis of entrapped lung was the consensus opinion of two interventional pulmonologists according to postdrainage imaging. Participants were randomly divided into development and validation sets. RESULTS: Both total movement and strain were significantly reduced in entrapped lung. Using data from the development set, the area under the receiver-operating curves for the diagnosis of entrapped lung was 0.86 (speckle tracking), 0.79 (M mode), and 0.69 (PEL). Using respective cutoffs of 6%, 1 mm, and 19 cm H2O on the validation set, the sensitivity/specificity was 71%/85% (speckle tracking), 50%/85% (M mode), and 40%/100% (PEL). CONCLUSIONS: This novel ultrasound technique can identify entrapped lung prior to effusion drainage, which could allow appropriate choice of definitive management (pleurodesis vs indwelling catheter), reducing the number of interventions required to treat malignant pleural effusion.