Placing a physical barrier between the patient and the stethoscope is one way to improve the protection of patients from germ transmission through the stethoscope.
Conditions
Interventions
Group 1: Initially:
Demographic information.
The following information will be transferred from the electronic medical record to the study database:
- Gender
- Body mass index (BMI) or body weight wi
Sponsors
Stethoglove GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: - Adult male and female patients (=18 years) elected for cardiac surgery - Ability to understand the purpose and risks of the clinical study and to provide signed and dated informed consent
Exclusion criteria
Exclusion criteria: - Known allergy or contact sensitization against the Stethoglove® material (thermoplastic urethane, TPU) - Patients with known HIV, Hepatitis B or C infections - Legal incapacity or limited legal capacity - Participation in an interventional clinical trial within 30 days prior to enrollment - Employees of the sponsor or patients who are employees or relatives of the users - Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints User group-specific rating of the acoustic quality of auscultations with Stethoglove® User group-specific rating of the handling of Stethoglove® as part of the routine practice Effect of body mass index (BMI) on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove® Effect of gender on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove® Effect of body-site (heart, lung, abdomen) on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove® | — |
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints Rating of the acoustic quality of auscultations with Stethoglove® by all users Rating of the handling of Stethoglove® as part of the routine practice by all users Safety Endpoints Number/percentage of patients reporting Stethoglove®-related adverse events Number of users reporting Stethoglove®-related adverse events | — |
Countries
Germany
Contacts
Public ContactMaximilian Emmert
Deutsches Herzzentrum Berlin (DHZB)Klinik für Herz-, Thorax- und Gefäßchirurgie
Outcome results
None listed