Pleural Effusion RecurrenceNCT03093610
Evaluation of Fluid Output Threshold for Safe Chest Tube Removal - A Potential Way to Decrease Length of Stay in Hospital and to Improve Postoperative Care After Lung Surgery?
A study testing Traditional and Test in people with Pleural Effusion Recurrence and Pulmonary Resection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Previous studies have shown that the removal of the chest tube after lung surgery significantly improves pain symptoms and lung function. The criteria for chest tube removal still remain vague in modern thoracic surgery and rely on personal experience instead of evidence-based criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion Recurrence, Pulmonary Resection, Chest Tube Management
- What is being tested?
- Traditional and Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 May 2019to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lobectomy/ Bilobectomy
- Segmentectomy
- Signed consent
- Age of majority
Who cannot join
- Pneumonectomy
- Atypical resections
- Empyema
- Pleural effusion (not related to surgery)
- Pleurodesis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Previous studies have shown that the removal of the chest tube after lung surgery significantly improves pain symptoms and lung function. The criteria for chest tube removal still remain vague in modern thoracic surgery and rely on personal experience instead of evidence-based criteria. Every hospital has its own traditional standard fluid threshold and believes in that without adapting and comparing it not even after introduction of newer and more minimal-invasive operation technique. According to literature the traditional fluid threshold is varying from 100 to 500 or even more millilitre in 24 hours. Since pleural fluid resorption is proportional to body weight the investigators believe that a body weight related approach of chest tube management would improve safety and would allow an earlier chest tube removal without a higher rate of complication. In this way the investigators believe in improving pain management and in achieving earlier discharge of the patient.
- Being tested
- Traditional, Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraditionalProcedure or surgery
Removal of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less.
TestProcedure or surgery
Removal of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less.
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | The chest tube in the traditional Group will be managed according to the current Guidelines of the investigators' department. Receives: Procedure: Traditional |
| Test group | Active comparator | The chest tube in the "Test Group" will constitute the experimental Group. The chest tube will be removed when the fluid production over 24h has reached a weight related threshold. Receives: Procedure: Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrent pleural effusions after chest tube removal
Evaluation of recurrent pleural effusion after chest tube removal
Measured: up to 6 weeks postoperative
Pain scores (VAS-Score)
Evaluation of Pain Scores after Chest tube removal
Measured: postoperative Period until 3 hours after Chest tube removal
Time Point of chest tube removal
postoperative day of chest tube removal
Measured: Postoperative, expected to be up to 1 week after surgery
Secondary outcomes (1)
Patient discharge
Time Point of Patient discharge
Measured: At time of discharge, on average 4-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start31 May 2019
- Primary completion10 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion RecurrenceStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Removal of the chest tube after air leakage has ceased and fluid Drainage is \< 200ml/24h Group 2: Removal of the chest tube after air leakage has ceased and fluid Drainage is \< 5ml/kg/24h
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Dorn, Study director, Chief, Department of General Thoracic Surgery, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093610
- Sponsor's protocol ID
- 14032017
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2017
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared, All participant Data will be encrypted
Publications
Bjerregaard LS, Jensen K, Petersen RH, Hansen HJ. Early chest tube removal after video-assisted thoracic surgery lobectomy with serous fluid production up to 500 ml/day. Eur J Cardiothorac Surg. 2014 Feb;45(2):241-6. doi: 10.1093/ejcts/ezt376. Epub 2013 Jul 19.
PubMed 23872457Xie HY, Xu K, Tang JX, Bian W, Ma HT, Zhao J, Ni B. A prospective randomized, controlled trial deems a drainage of 300 ml/day safe before removal of the last chest drain after video-assisted thoracoscopic surgery lobectomy. Interact Cardiovasc Thorac Surg. 2015 Aug;21(2):200-5. doi: 10.1093/icvts/ivv115. Epub 2015 May 15.
PubMed 25979532Zhang Y, Li H, Hu B, Li T, Miao JB, You B, Fu YL, Zhang WQ. A prospective randomized single-blind control study of volume threshold for chest tube removal following lobectomy. World J Surg. 2014 Jan;38(1):60-7. doi: 10.1007/s00268-013-2271-7.
PubMed 24158313Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066.
PubMed 18242249Younes RN, Gross JL, Aguiar S, Haddad FJ, Deheinzelin D. When to remove a chest tube? A randomized study with subsequent prospective consecutive validation. J Am Coll Surg. 2002 Nov;195(5):658-62. doi: 10.1016/s1072-7515(02)01332-7.
PubMed 12437253Irshad K, Feldman LS, Chu VF, Dorval JF, Baslaim G, Morin JE. Causes of increased length of hospitalization on a general thoracic surgery service: a prospective observational study. Can J Surg. 2002 Aug;45(4):264-8.
PubMed 12174980Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.
PubMed 22219425Mueller XM, Tinguely F, Tevaearai HT, Ravussin P, Stumpe F, von Segesser LK. Impact of duration of chest tube drainage on pain after cardiac surgery. Eur J Cardiothorac Surg. 2000 Nov;18(5):570-4. doi: 10.1016/s1010-7940(00)00515-7.
PubMed 11053819STEWART PB. The rate of formation and lymphatic removal of fluid in pleural effusions. J Clin Invest. 1963 Feb;42(2):258-62. doi: 10.1172/JCI104712. No abstract available.
PubMed 13984113
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Output Threshold for Safe Chest Tube Removal - A Potential Way to Decrease Length of Stay in Hospital and to Improve Postoperative Care After Lung Surgery?
- ClinicalTrials.gov ID
- NCT03093610
- Acronym / sponsor ID
- 14032017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 31 May 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have shown that the removal of the chest tube after lung surgery significantly improves pain symptoms and lung function. The criteria for chest tube removal still remain vague in modern thoracic surgery and rely on personal experience instead of evidence-based criteria. Every hospital has its own traditional standard fluid threshold and believes in that without adapting and comparing it not even after introduction of newer and more minimal-invasive operation technique. According to literature the traditional fluid threshold is varying from 100 to 500 or even more millilitre in 24 hours. Since pleural fluid resorption is proportional to body weight the investigators believe that a body weight related approach of chest tube management would improve safety and would allow an earlier chest tube removal without a higher rate of complication. In this way the investigators believe in improving pain management and in achieving earlier discharge of the patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Group 1: Removal of the chest tube after air leakage has ceased and fluid Drainage is < 200ml/24h Group 2: Removal of the chest tube after air leakage has ceased and fluid Drainage is < 5ml/kg/24h
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Procedure: TraditionalThe chest tube in the traditional Group will be managed according to the current Guidelines of the investigators' department. |
| Test group | Active comparator | Procedure: TestThe chest tube in the "Test Group" will constitute the experimental Group. The chest tube will be removed when the fluid production over 24h has reached a weight related threshold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lobectomy/ Bilobectomy
- Segmentectomy
- Signed consent
- Age of majority
Key exclusion criteria (6 listed)
- Pneumonectomy
- Atypical resections
- Empyema
- Pleural effusion (not related to surgery)
- Pleurodesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TraditionalRemoval of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less. | Procedure or surgery | Traditional |
| TestRemoval of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less. | Procedure or surgery | Test group |
Primary outcome
Number of recurrent pleural effusions after chest tube removal
Time frame: up to 6 weeks postoperative
Evaluation of recurrent pleural effusion after chest tube removal
Pain scores (VAS-Score)
Time frame: postoperative Period until 3 hours after Chest tube removal
Evaluation of Pain Scores after Chest tube removal
Time Point of chest tube removal
Time frame: Postoperative, expected to be up to 1 week after surgery
postoperative day of chest tube removal
1 secondary outcome
Patient discharge
Time frame: At time of discharge, on average 4-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 23872457Bjerregaard LS, Jensen K, Petersen RH, Hansen HJ. Early chest tube removal after video-assisted thoracic surgery lobectomy with serous fluid production up to 500 ml/day. Eur J Cardiothorac Surg. 2014 Feb;45(2):241-6. doi: 10.1093/ejcts/ezt376. Epub 2013 Jul 19.
- Background: PubMed 25979532Xie HY, Xu K, Tang JX, Bian W, Ma HT, Zhao J, Ni B. A prospective randomized, controlled trial deems a drainage of 300 ml/day safe before removal of the last chest drain after video-assisted thoracoscopic surgery lobectomy. Interact Cardiovasc Thorac Surg. 2015 Aug;21(2):200-5. doi: 10.1093/icvts/ivv115. Epub 2015 May 15.
- Background: PubMed 24158313Zhang Y, Li H, Hu B, Li T, Miao JB, You B, Fu YL, Zhang WQ. A prospective randomized single-blind control study of volume threshold for chest tube removal following lobectomy. World J Surg. 2014 Jan;38(1):60-7. doi: 10.1007/s00268-013-2271-7.
- Background: PubMed 18242249Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066.
- Background: PubMed 12437253Younes RN, Gross JL, Aguiar S, Haddad FJ, Deheinzelin D. When to remove a chest tube? A randomized study with subsequent prospective consecutive validation. J Am Coll Surg. 2002 Nov;195(5):658-62. doi: 10.1016/s1072-7515(02)01332-7.
- Background: PubMed 12174980Irshad K, Feldman LS, Chu VF, Dorval JF, Baslaim G, Morin JE. Causes of increased length of hospitalization on a general thoracic surgery service: a prospective observational study. Can J Surg. 2002 Aug;45(4):264-8.
- Background: PubMed 22219425Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.
- Background: PubMed 11053819Mueller XM, Tinguely F, Tevaearai HT, Ravussin P, Stumpe F, von Segesser LK. Impact of duration of chest tube drainage on pain after cardiac surgery. Eur J Cardiothorac Surg. 2000 Nov;18(5):570-4. doi: 10.1016/s1010-7940(00)00515-7.
- Background: PubMed 13984113STEWART PB. The rate of formation and lymphatic removal of fluid in pleural effusions. J Clin Invest. 1963 Feb;42(2):258-62. doi: 10.1172/JCI104712. No abstract available.
- Individual participant dataSharing planned: No. No IPD will be shared, All participant Data will be encrypted
Related trials for Pleural Effusion Recurrence
Active, not recruitingPhase 2
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Advanced Cancer, Pleural Effusion
Not yet recruiting
Comparison of Talc Slurry Versus Talc Insufflation: A Study on Effectiveness, Safety, and Hospital Outcomes in Pleurodesis
Pneumothorax Spontaneous Primary, Pneumothorax Spontaneous Secondary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Dorn study director
Chief, Department of General Thoracic Surgery, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional and Test in people with Pleural Effusion Recurrence and Pulmonary Resection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recurrent pleural effusions after chest tube removal (time frame: up to 6 weeks postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093610, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.