Testing a novel, self-contained chest drainage system (THOPAZ+) for post-operative cardiac drainage

Randomized controlled trial of a novel, self-contained chest drainage system in cardiac surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14884587

Enrollment

120

Registered

2019-06-07

Start date

2015-09-17

Completion date

Unknown

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac surgery Surgery

Interventions

This study compared the conventional chest drainage system (Argyle Aqua-Seal, Covidien, USA) with the new THOPAZ+ digital self-contained system from the end of cardiac surgery until the chest tube rem

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Patient safety and Satisfaction Assessment of the hospital personnel. 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. 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). -Ease of use -No/reduced milking -Mobility of patients -Noise reduction -Gain of time -Security for patients -How useful were the alarms?	—

Measure

Time frame

Patient safety and Satisfaction Assessment of the hospital personnel. 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. 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). -Ease of use -No/reduced milking -Mobility of patients -Noise reduction -Gain of time -Security for patients -How useful were the alarms?

—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026