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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Luca Barozzi
Scientific

Cardiac Surgery
University Hospital of Verona
Piazzale le Stefani 1
Verona
37126
Italy

ORCiD logoORCID ID 0000-0001-5297-0058
Phone 0039 347 2739 436
Email luca.barozzi@ospedaleuniverona.it

Study information

Study designInterventional single centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomized controlled trial of a novel, self-contained chest drainage system in cardiac surgery
Study acronymThopCard2
Study objectivesImprovement 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) studiedCardiac surgery
InterventionThis 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureAdequecy 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 measuresPatient 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 date24/09/2014
Completion date20/06/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants120 patients were randomized for the two drainage systems.
Key inclusion criteria1. Adult aged 18 - 80 years
2. Scheduled to undergo elective, first-time: CABG, valve surgeries and combinations with cardio-pulmonary bypass (CPB)
Key exclusion criteria1. 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 enrolment17/09/2015
Date of final enrolment14/06/2016

Locations

Countries of recruitment

  • Italy

Study participating centre

Department of Cardiac Surgery
University Hospital
Piazzale le Stefani 1
Verona
37126
Italy

Sponsor information

Medela AG
Industry

Lättichstrasse 4b
BAAR
6341
Switzerland

Phone +41 41 769 54 94
Email Inez.Cregan@medela.ch
ROR logo "ROR" https://ror.org/02cedh792

Funders

Funder type

Industry

Medela AG

No information available

Results and Publications

Intention to publish date01/09/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planBMC Critical Care
IPD sharing planThe 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