Testing a novel, self-contained chest drainage system (THOPAZ+) for post-operative cardiac drainage
| ISRCTN | ISRCTN14884587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14884587 |
| Secondary identifying numbers | 584CESC |
- Submission date
- 29/05/2019
- Registration date
- 07/06/2019
- Last edited
- 27/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Most cardiac procedures still require the use of cardiopulmonary bypass (CPB) and a sternotomy. One of the complications after such procedures is bleeding, since patients have to be fully anti-coagulated during CPB and therefore require post-operative chest drainage.
Aim: A new, self-contained, electronic, continuous pump-driven chest drainage system is compared for the first time in an RCT to a traditional wall-suction system in cardiac surgery.
Who can participate?
Adult elective cardiac patients undergoing CABG and/or valve surgery.
What does the study involve?
Patients undergoing cardiac surgery require post-operative chest-drainage in order to evacuate blood and clot formation. This is achieved with one or several chest-tubes which are hooked to a conventional canister system drained by vacuum. The aim of our study was to assess a new, self-contained, battery-operated, digital drainage system (THOPAZ+) and to compare it to a conventional system. Our prospective, randomized clinical trial included 120 patients undergoing elective routine cardiac surgery. They were randomized between the group with conventional and the group with THOPAZ+ drainage.
What are the possible benefits and risks of participating?
The benefits of the new system are a continuous drainage from the operating room until the chest-tube removal, the possibility to mobilize the patient and the presence of alarms on the THOPAZ+ system and a shorter drainage duration which may have a positive impact on the outcome of the patient.
Where is the study run from?
Department of Cardiac Surgery, University Hospital, Verona, Italy.
When is the study starting and how long is it expected to run for?
September 2015 to June 2016
Who is funding the study?
Medela AG, Switzerland
Who is the main contact?
Dr Luca Barozzi,
luca.barozzi@ospedaleuniverona.it
Contact information
Scientific
Cardiac Surgery
University Hospital of Verona
Piazzale le Stefani 1
Verona
37126
Italy
 ORCID ID |
0000-0001-5297-0058 |
|---|---|
| Phone | 0039 347 2739 436 |
| luca.barozzi@ospedaleuniverona.it |
Study information
| Study design | Interventional single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomized controlled trial of a novel, self-contained chest drainage system in cardiac surgery |
| Study acronym | ThopCard2 |
| Study objectives | Improvement of chest drainage: we have investigated a new chest drainage system THOPAZ+ (Medela AG, Switzerland) to improve and simplify the management of chest drainage after cardiac surgical procedures and which gives the patient a small, mobile, user-friendly, continuous suction from the operating table to the ICU/ward. |
| Ethics approval(s) | Approved 28/07/2015, Ethics Committee of the University of Verona (Borgo Trento, P. le A. Stefani, 1-37126 Verona, Italy; 045 8123236; comitatoetico.veronarovigo@ospedaleuniverona.it), ref: 584CESC. |
| Health condition(s) or problem(s) studied | Cardiac surgery |
| Intervention | 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 removal. Randomization: Patients were allocated to either the usual suction system or the Thopaz+ pump using block randomization, with blocks of 4 or 6 (block size is also random). Group allocation was put in sealed envelopes, which were opened after surgery, just before the OR nurse opened the tubing system. Thus, the surgical team was blinded to the suction system during the surgery. All the data were collected prospectively during the study by two surgical residents and supervised by Dr. Luca Barozzi. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 | 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? |
| Overall study start date | 24/09/2014 |
| Completion date | 20/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 patients were randomized for the two drainage systems. |
| Key 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) |
| Key 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 |
| Date of first enrolment | 17/09/2015 |
| Date of final enrolment | 14/06/2016 |
Locations
Countries of recruitment
- Italy
Study participating centre
Piazzale le Stefani 1
Verona
37126
Italy
Sponsor information
Industry
Lättichstrasse 4b
BAAR
6341
Switzerland
| Phone | +41 41 769 54 94 |
|---|---|
| Inez.Cregan@medela.ch | |
"ROR" |
https://ror.org/02cedh792 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | BMC Critical Care |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on special request from Dr. Luca Barozzi, luca.barozzi@ospedaleuniverona.it with the following access criteria: detailed description for which purpose the anonymized data, or part of the data, will be used and only after having received permission from the Ethical Commission of the University of Verona. |
Editorial Notes
27/08/2019: Internal review.
07/06/2019: Trial’s existence confirmed by the Ethics Committee of the University of Verona
