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Flexible Nasendoscope with Disposable-Sheath System Compared with Standard Nasendoscopy: Randomized Trial

Winter, S.C., Thirwell, A., & Jervis, P. (2002). Clin Otolaryngol Allied Sci, 27, 81-3.

This article by Winter et al describes a randomized trial in which flexible nasal endoscopy using EndoSheath® Technology was compared with standard flexible nasal endoscopy in 100 patients (50 in each group). The study assessed setup times, ease of setup, patient comfort during the endoscopic procedure, and image quality with and without a disposable sheath. The same nasal endoscope (3-mm Olympus, Tokyo, Japan) was used for all procedures. If no disposable sheath had been applied to the endoscope during a procedure, reprocessing of the instrument before use in another patient included immersion in glutaraldehyde for 10 minutes, in accordance with departmental protocol. When EndoSheath® Technology was used, the endoscope was reprocessed by removing the disposable sheath and cleaning the instrument with alcohol wipes. Setup times (which did not include the 10 minutes of glutaraldehyde immersion for the unsheathed endoscope) were measured by an independent timekeeper. For each clinical procedure, the assisting nurse rated the ease of setup and cleaning according to a 10-point visual analog scale, with 0 indicating bad and 10 good. Patients used the same scale to record their comfort during endoscopy. The one endoscopist in the study rated the ease of passage of the endoscope and the quality of the image (nonblinded evaluation). Several images were recorded with a video system and subsequently rated for quality by an otolaryngologist blinded to whether the EndoSheath® Technology had been used during the endoscopic procedure.

Winter et al found no significant differences (with 99% confidence intervals [CIs]) between the sheathed and unsheathed nasal endoscope in setup time, patients’ perception of the comfort of their procedure, or the physician’s perception of the ease of passage or image quality. There were also no significant differences (99% CI) between the image-quality ratings of the nonblinded endoscopist and those of the blinded otolaryngologist.

Winter et al concluded that the use of disposable sheaths allows more nasal endoscopic procedures to be performed with each instrument because the 10-minute glutaraldehyde immersion is avoided. The authors also noted that they advocate the use of EndoSheath® Technology as a physical barrier that provides protection against the risk of crosscontamination between patients. Winter et al explained that although the risk of such contamination is not high in otolaryngologic endoscopy, it still exists, particularly because of the association between prion diseases and lymphoid tissue of the head and neck.

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