Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Luca Barozzi
ORCID ID
http://orcid.org/0000-0001-5297-0058
Contact details
Cardiac Surgery
University Hospital of Verona
Piazzale le Stefani 1
Verona
37126
Italy
0039 347 2739 436
luca.barozzi@ospedaleuniverona.it
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
584CESC
Study information
Scientific title
Randomized controlled trial of a novel, self-contained chest drainage system in cardiac surgery
Acronym
ThopCard2
Study hypothesis
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
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.
Study design
Interventional single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
24/09/2014
Overall trial end date
20/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 patients were randomized for the two drainage systems.
Participant 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
Recruitment start date
17/09/2015
Recruitment end date
14/06/2016
Locations
Countries of recruitment
Italy
Trial participating centre
Department of Cardiac Surgery
University Hospital
Piazzale le Stefani 1
Verona
37126
Italy
Sponsor information
Organisation
Medela AG
Sponsor details
Lättichstrasse 4b
BAAR
6341
Switzerland
+41 41 769 54 94
Inez.Cregan@medela.ch
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Medela AG
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
BMC Critical Care
IPD sharing statement:
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.
Intention to publish date
01/09/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list