Condition category
Surgery
Date applied
29/05/2019
Date assigned
07/06/2019
Last edited
07/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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)

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.
Methods: 120 adult elective cardiac patients undergoing CABG and/or valve surgery were randomized to the study or control group. Both groups had similar pre/intra-operative demographics: age 67.8 vs. 67.0 years, Euroscore 2.3 vs. 2.2 and BSA 1.92 vs. 1.91 m2. Additionally, a satisfaction assessment score was performed by 52 staff members.
Results: Given homogenous intra-operative variables, total chest-tube drainage was comparable among groups (566 vs. 640 ml; ns), but the study group showed more efficient fluid collection during the early post-operative phase (p = 0.006 and p = 0.01) due to continuous suction compared to 11.5 minutes off-suction time in the control group. Blood, cell saver transfusions and post-operative hemoglobin values were similar in both groups. The study group also experienced quicker drain removal (29.8 vs 38.4 hours). Seven crossovers from the study to the control group were registered but no patient had drain-related complications.
Conclusion: The new, self-contained, electronic, continuous pump-driven drainage system showed more efficient early drainage of the chest cavity and was as reliable as conventional systems. Quicker drain removal might impact on ICU stay and reduce costs. Additional advantages are portable size, battery operation, patient mobility, noiseless function, digital indications and alarms. The satisfaction assessment of the new system by the staff revealed a higher score when compared to the traditional wall suction chest drainage system.

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2019: Trial’s existence confirmed by the Ethics Committee of the University of Verona