Back to resultsEvaluation 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?
Primary Purpose
Pleural Effusion Recurrence, Pulmonary Resection, Chest Tube Management
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Traditional
Test
Sponsored by
About this trial
This is an interventional prevention trial for Pleural Effusion Recurrence
Eligibility Criteria
Inclusion criteria:
- Lobectomy/ Bilobectomy
- Segmentectomy
- Signed consent
- Age of majority
Exclusion criteria:
- Pneumonectomy
- Atypical resections
- Empyema
- Pleural effusion (not related to surgery)
- Pleurodesis
- Pregnancy
Sites / Locations
- Bern University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traditional
Test group
Arm Description
The chest tube in the traditional Group will be managed according to the current Guidelines of the investigators' department.
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.
Outcomes
Primary Outcome Measures
Number of recurrent pleural effusions after chest tube removal
Evaluation of recurrent pleural effusion after chest tube removal
Pain scores (VAS-Score)
Evaluation of Pain Scores after Chest tube removal
Time Point of chest tube removal
postoperative day of chest tube removal
Secondary Outcome Measures
Patient discharge
Time Point of Patient discharge
Full Information
NCT ID
NCT03093610
First Posted
March 22, 2017
Last Updated
December 19, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT03093610
Brief 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?
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?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion Recurrence, Pulmonary Resection, Chest Tube Management
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care Provider
Masking Description
The operating surgeon does not know to which group the Patient will be attributed to.
Allocation
Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
The chest tube in the traditional Group will be managed according to the current Guidelines of the investigators' department.
Arm Title
Test group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional
Intervention Description
Removal of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less.
Intervention Type
Procedure
Intervention Name(s)
Test
Intervention Description
Removal of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less.
Primary Outcome Measure Information:
Title
Number of recurrent pleural effusions after chest tube removal
Description
Evaluation of recurrent pleural effusion after chest tube removal
Time Frame
up to 6 weeks postoperative
Title
Pain scores (VAS-Score)
Description
Evaluation of Pain Scores after Chest tube removal
Time Frame
postoperative Period until 3 hours after Chest tube removal
Title
Time Point of chest tube removal
Description
postoperative day of chest tube removal
Time Frame
Postoperative, expected to be up to 1 week after surgery
Secondary Outcome Measure Information:
Title
Patient discharge
Description
Time Point of Patient discharge
Time Frame
At time of discharge, on average 4-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Lobectomy/ Bilobectomy
Segmentectomy
Signed consent
Age of majority
Exclusion criteria:
Pneumonectomy
Atypical resections
Empyema
Pleural effusion (not related to surgery)
Pleurodesis
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Dorn
Organizational Affiliation
Chief, Department of General Thoracic Surgery, Bern University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bern University Hospital
City
Bern
ZIP/Postal Code
3007
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared, All participant Data will be encrypted
Citations:
PubMed Identifier
23872457
Citation
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.
Results Reference
background
PubMed Identifier
25979532
Citation
Xie 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.
Results Reference
background
PubMed Identifier
24158313
Citation
Zhang 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.
Results Reference
background
PubMed Identifier
18242249
Citation
Cerfolio 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.
Results Reference
background
PubMed Identifier
12437253
Citation
Younes 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.
Results Reference
background
PubMed Identifier
12174980
Citation
Irshad 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. Erratum In: Can J Surg. 2003 Dec;46(6):466. Can J Surg. 2004 Feb;47(1):69.
Results Reference
background
PubMed Identifier
22219425
Citation
Refai 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.
Results Reference
background
PubMed Identifier
11053819
Citation
Mueller 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.
Results Reference
background
PubMed Identifier
13984113
Citation
STEWART 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.
Results Reference
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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?
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