Testing a novel, self-contained chest drainage system (THOPAZ+) for post-operative cardiac drainage
Not Applicable
Completed
- Conditions
- Cardiac surgerySurgery
- Registration Number
- ISRCTN14884587
- Lead Sponsor
- Medela AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Adult aged 18 - 80 years
2. Scheduled to undergo elective, first-time: CABG, valve surgeries and combinations with cardio-pulmonary bypass (CPB)
Exclusion Criteria
1. Unstable angina
2. Emergency procedures
3. Off-pump surgery
4. Re-operation
5. Anti-coagulation or anti-platelet therapy (except aspirin cardio) until surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adequecy of chest drainage with THOPAZ+ measured on the digital read-out of the THOPAZ+ (in ml of drainage fluid) at the following time points: end of OR, before and after transport to ICU, on ICU (hourly), POD1, and at chest-tube removal.
- Secondary Outcome Measures
Name Time Method <br> Patient safety and Satisfaction Assessment of the hospital personnel.<br> 1. The patient safety was part of the routine ICU care of the patient and special attention was given to the functioning of the THOPAZ+ chest drainage system, e.g. fluid collection, air leak.<br> 2. The satisfaction assessment of the hospital personnel was performed with a short, internet-based form was filled by the users according to their specialty, e.g. cardiac surgeons, anesthetists, nurses to measure the following characteristics of the device on a visual analog scale (from 0 to 10).<br> -Ease of use<br> -No/reduced milking<br> -Mobility of patients<br> -Noise reduction<br> -Gain of time<br> -Security for patients<br> -How useful were the alarms?<br>