Performance of a new single-use bronchoscope versus a marketed single-use comparator: a bench study

Abstract

Background Single-use flexible bronchoscopes eliminate cross contamination from reusable bronchoscopes and are cost-effective in a number of clinical settings. The present bench study aimed to compare the performance of a new single-use bronchoscope (Boston Scientific EXALT Model B) to a marketed single-use comparator (Ambu aScope 4), each in slim, regular and large diameters. Methods Three bronchoscopy tasks were performed: water suction and visualization, “mucus” mass (synthetic mucoid mixture) suctioned in 30 s, and “mucus” plug (thicker mucoid mixture) suction. Suction ability, task completion times, and subjective ratings of visualization and overall performance on a scale of one to 10 (best) were compared. All bronchoscopy tasks were completed by 15 physicians representing diversity in specialization including pulmonary, interventional pulmonary, critical care, anesthesia, and thoracic surgery. Each physician utilized the six bronchoscope versions with block randomization by bronchoscope and task. Results Aspirated mean mass of “mucus” using EXALT Model B Regular was comparable to that for an aScope 4 Large (41.8 ± 8.3 g vs. 41.5 ± 5.7 g respectively, p = 0.914). In comparisons of scopes with the same outer diameter, the aspirated mean mass by weight of water and “mucus” was significantly greater for EXALT Model B than for aScope 4 (p < 0.001 for all three diameters). Mean ratings for visualization attributes were significantly better for EXALT Model B compared to aScope 4 (p-value range 0.001−0.029). Conclusion A new single-use bronchoscope provided strong suction capability and visualization compared to same-diameter marketed single-use comparators in a bench model simulation.

Single Use or Disposable Flexible Bronchoscopes: Bench Top and Preclinical Comparison of Currently Available Devices

“…Our study also assessed only one scope size; however, better suction was identified in another study across the range of scope sizes comparing Boston and AMBU SUFB. 24 In addition, our low-fidelity simple simulation tubing is clearly not validated in any study as a training tool.…”

“…Although there have not been direct monitor comparisons, another preclinical study identified a preference for the Boston Exalt TM monitor over the aView TM 2 Advanced monitor. 24 Due to in availability of all company monitors at the time of clinical testing, we did not report on monitor preference which is a critique of our analysis.…”

“…The reason for this is probably the clamshell shape of the suction channel that replicates another recent comparison of Boston with Ambu SUFB. 24 Our center has subsequently published a pilot clinical study of 24 patients using the Boston SUFB highlighting the ability to control hemoptysis both in the endoscopy suite and OR. 30 Clinical trials clearly are warranted.…”

“… 22 , 23 After completing our assessment, another study was published using a similar “pseudo-mucus” composition. 24 Four scenarios were tested: 0.9% sodium chloride 50 mL without forceps 0.9% sodium chloride 50 mL with forceps Pseudo-mucus 20 mL without forceps Pseudo-mucus 20 mL with forceps Two trials for each of 2 company scopes were performed (16 suction trials per vendor).…”

“…22,23 After completing our assessment, another study was published using a similar "pseudo-mucus" composition. 24 Four scenarios were tested:…”