A clinical study to evaluate the safe and effective use of Stethoglove, a single use stethoscope cover to reduce pathogen transmission during auscultation

Objectives Stethoscopes carry a significant risk for pathogen transmission. Here, the safe use and performance of Stethoglove®, a non-sterile, single-use cover for stethoscopes, 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 Stethoglove®. The participating HCPs (n=34) rated each auscultation with Stethoglove® on a 5-point Likert scale. The mean ratings of acoustic quality and Stethoglove® handling were defined as primary and secondary performance endpoint. Results 534 auscultations with Stethoglove® 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 Stethoglove® handling was rated at 3.7±0.8 (mean) with a total of 96.4% of all auscultations being rated at least 3/5. Conclusions Using a real-world setting, this study demonstrates that Stethoglove® can be safely and effectively used as cover for stethoscopes during auscultation. Stethoglove® may therefore represent a useful and easy-to-implement tool for preventing stethoscope-mediated infections. ### Competing Interest Statement MYE is the principal investigator of the study and a scientific advisor to Stethoglove GmbH. Outside the submitted work: 617 V.F. has relevant (institutional) financial activities with following commercial entities: Medtronic 618 GmbH, Biotronik SE & Co., Abbott GmbH & Co. KG, Boston Scientific, Edwards Lifesciences, 619 Berlin Heart, Novartis Pharma GmbH, JOTEC GmbH and Zurich Heart in relation to educational 620 grants (including travel support), fees for lectures and speeches, fees for professional consultation 621 and research and study funds. ### Clinical Trial EUDAMED no. CIV-21-09-037762 ### Funding Statement This work was supported by Stethoglove GmbH, Hamburg Germany ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the local ethics committee (Landesamt fuer Gesundheit und Soziales, Berlin, Germany) (21-702-MP Mono -IVE17) and the federal authority (Bundesinstitut fuer Arzneimittel und Medizinprodukte, Germany) (94.1-03-5660-13526) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors * BMI : Body-Mass-Index HCI : Healthcare-associated infection HCP : Healthcare professional ICU : Intensive care unit TPU : Thermoplastic urethane