A clinical study to evaluate the safe and effective use of a new, single use stethoscope cover to enable reduction in pathogen transmission during auscultation

Abstract

Objectives: Stethoscopes carry a significant risk for pathogen transmission. Here, the safe use and performance of a new, non-sterile, single-use stethoscope cover (SC), that is impermeable for pathogens, was investigated by different healthcare professionals (HCPs) in the postoperative care setting of an intensive care unit (ICU).

Methods: Fifty-four patients underwent routine auscultations with the use of the SC (Stethoglove^®, Stethoglove GmbH, Hamburg, Germany). The participating HCPs (n = 34) rated each auscultation with the SC on a 5-point Likert scale. The mean ratings of acoustic quality and the SC handling were defined as primary and secondary performance endpoint.

Results: 534 auscultations with the SC were performed (average 15.7/user) on the lungs (36.1%), the abdomen (33.2%), the heart (28.8%), or other body-sites (1.9%). No adverse device-effects occurred. The acoustic quality was rated at 4.2 ± 0.7 (mean) with a total of 86.1% of all auscultations being rated at least as 4/5, and with no rating as below 2. The SC handling was rated at 3.7 ± 0.8 (mean) with a total of 96.4% of all auscultations being rated at least 3/5.

Conclusion: Using a real-world setting, this study demonstrates that the SC can be safely and effectively used as cover for stethoscopes during auscultation. The SC may therefore represent a useful and easy-to-implement tool for preventing stethoscope-mediated infections.Study Registration: EUDAMED no. CIV-21-09-037762.

Keywords: auscultation; nosocomial infections; polymer; stethoscope; transmission.

Figure 1

Product image of single use glove.

Figure 2

Product handling images.

Figure 3

Distribution of ratings of auscultation quality among the four user groups. User group 4: Fully trained nurses with <10 years of experience, user group 3: nurses with >10 years of experience, user group 3: Physicians in specialty training (e.g., residents), user group 1: Fully trained physicians (e.g., senior physician, board-certified physician, medical specialist, physicians with at least 8 years of working experience).

Figure 4

Distribution of ratings of product handling among the four user groups. User group 4: Fully trained nurses with <10 years of experience, user group 3: nurses with >10 years of experience, user group 3: Physicians in specialty training (e.g., residents), user group 1: Fully trained physicians (e.g., senior physician, board-certified physician, medical specialist, physicians with at least 8 years of working experience).