Plain English Summary
Background and study aims
When a section (lobe) of the lung has been removed by surgery from the chest, it is necessary to insert a chest drain (a plastic tube), so that air and fluid can be removed safely, and the remaining lung tissue can expand. Removing the air and fluid is routinely done by either applying suction, or passively with no suction.
The aim of this study is to see if there is a difference in the duration of air-leak when applying a high external suction to the chest drain versus a low external suction.
Who can participate?
Adults over the age of 18 years undergoing lung lobe surgery
What does the study involve?
Following surgery for removal of lobes of the lung participants are randomly assigned to one of two groups. Those in the first group receive low external suction whilst those in the second group receive high external suction, via a plastic tube (chest drain).Participants are followed up in the outpatient clinic two weeks after discharge from hospital.
What are the possible benefits and risks of participating?
Participants benefit from helping define new guidelines for postoperative care. There are no risks involved that are beyond what to expect after undergoing usual lung surgery.
Where is the study run from?
Odense University Hospital (Denmark)
When is the study starting and how long is it expected to run for?
March 2015 – April 2016
Who is funding the study?
Odense University Hospital (Denmark)
Who is the main contact?
Dr Marike Lijkendijk (Scientific)
elle.lijkendijk@rsyd.dk
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Thopaz 2.0
Study information
Scientific title
The influence of suction on chest drain duration and fluid output after lobectomy using only electronic chest drainage systems – a randomized clinical trial
Acronym
Study hypothesis
External suction on the chest drain after lobectomy has no influence on the duration of the chest drain.
The general theory is that application of high suction maintains alveo-pleural leakage and prolongs air-leak. On the other hand it is believed in the literature that external suction has to be applied in order for the residual lung to be fully expanded after lobectomy.
Ethics approval(s)
Ethics approval not required: Letter received 15/01/2015 from The Regional Ethics Committee (Southern Region of Denmark) deciding the study as a quality securing - or quality developing project, which falls out of the scope of the committees law given definition of a health scientific research project.
Study design
Single-center randomized study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Hospital
Study type
Other
Patient information sheet
Not available in web format, please use contact details to request participant information sheet
Condition
Pulmonary lobectomy
Intervention
Following pulmonary lobectomy (lower or upper lobes) patients are randomly assigned (1:1) by sequentially numbered, opaque, and sealed envelopes to one of two groups. Participants receive either low external suction (–5 cm H2O) or high external suction (–20 cm H2O) via a size 24 French silicone chest drain connected to an electronic drainage device. All other postoperative care is the same in both groups.
Treatment ends when the chest drains are removed. Both arms use a chest drainage removal algorithm; patients have to be well pain managed and mobilized. There is no upper limit on fluid output (providing it is serous and no chylous). Air leak is < 20 ml/min with no spikes for 6 hours or < 50 ml/min with no spikes for 12 hours.
Participants are followed up in the outpatient clinic two weeks after discharge from hospital.
Intervention type
Procedure/Surgery
Primary outcome measure
Duration of air leakage is measured using the time of end of surgery and the time when the chest drain was removed (information from electronic patient charts).
Secondary outcome measures
1. Fluid output is measured by recording measurements from the drainage device cannister on the patient chart.
2. Length of stay is recorded from hospital records.
3. Re-insertion of chest drains (complications) is recorded using the information from the patient chart.
Overall study start date
01/03/2015
Overall study end date
30/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Admitted for lobectomy (by thoracotomy or video-assisted thoracoscopic
surgery [VATS] as decided by the surgeon)
2. Aged over 18 years
3. Ability to give informed consent
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
100
Total final enrolment
106
Participant exclusion criteria
1. Previous history of pulmonary or cardiac surgery
2. Expected difficulties with postoperative mobilization
3. Participation in concomitant research studies in our department in which a different chest drainage protocol could influence these results
4. Anticipation of a need for postoperative mechanical ventilation
5. Insertion of more than one chest drain
6. Bilobectomy or middle lobectomy
Recruitment start date
03/03/2015
Recruitment end date
01/04/2016
Locations
Countries of recruitment
Denmark
Study participating centre
Department of Cardiothoracic and Vascular Surgery
Odense University Hospital
J. B. Winsløws Vej 4
Odense
5000
Denmark
Sponsor information
Organisation
Department of Cardiothoracic and Vascular Surgery
Sponsor details
Odense University Hospital
J. B. Winsløws Vej 4
Odense
5000
Denmark
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
University/education
Funder name
Odense Universitetshospital
Alternative name(s)
Svendborg Sygehus, Odense University Hospital, OUH
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Denmark
Results and Publications
Publication and dissemination plan
The authors are intending to publish the air-leakage results on chest drain duration.
09/04/2018: Results presented at Society of Thoracic Surgeons 53rd Annual meeting 2017 (https://www.sts.org/sites/default/files/documents/53AM_AbstractBook.pdf)
Intention to publish date
01/01/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Marike Lijkendijk (elle.lijkendijk@rsyd.dk)
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2018 | Yes | No | |
| Results article | results | 01/06/2019 | 09/01/2020 | Yes | No |