Condition category
Surgery
Date applied
26/03/2018
Date assigned
13/04/2018
Last edited
11/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marike Lijkendijk

ORCID ID

Contact details

Department of Cardiothoracic and Vascular Surgery
Odense University Hospital
J.B. Winsløws Vej 4
Odense
5000
Denmark

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2015

Overall trial end date

30/04/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial 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

Funders

Funder type

University/education

Funder name

Odense Universitetshospital

Alternative name(s)

Odense University Hospital, Svendborg Sygehus, OUH

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

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)

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Marike Lijkendijk (elle.lijkendijk@rsyd.dk)

Intention to publish date

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29174779

Publication citations

Additional files

Editorial Notes