Clinical study to investigate the safe and effective use of Stethoglove® by health care professionals under real-life conditions
- Conditions
- 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.
- Registration Number
- DRKS00025984
- Lead Sponsor
- Stethoglove GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
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
- 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoints<br>Rating of the acoustic quality of auscultations with Stethoglove® by all users<br>Rating of the handling of Stethoglove® as part of the routine practice by all users<br>Safety Endpoints<br>Number/percentage of patients reporting Stethoglove®-related adverse events<br>Number of users reporting Stethoglove®-related adverse events
- Secondary Outcome Measures
Name Time Method Secondary Endpoints<br>User group-specific rating of the acoustic quality of auscultations with Stethoglove®<br>User group-specific rating of the handling of Stethoglove® as part of the routine practice<br>Effect of body mass index (BMI) on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove®<br>Effect of gender on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove®<br>Effect of body-site (heart, lung, abdomen) on the overall and user group-specific rating of the acoustic quality of auscultations with Stethoglove®