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?

Pulmonary Resection Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093610
• Other study ID #: 14032017
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: March 30, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 337
• Est. completion date: March 30, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Lobectomy/ Bilobectomy
• Segmentectomy
• Signed consent
• Age of majority

Exclusion criteria:

• Pneumonectomy
• Atypical resections
• Empyema
• Pleural effusion (not related to surgery)
• Pleurodesis
• Pregnancy

Related Conditions & MeSH terms

• Chest Tube Management
• Pleural Effusion
• Pleural Effusion Recurrence
• Pulmonary Resection
• Recurrence

Intervention

Procedure:
• Traditional
Removal of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less.
• Test
Removal of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less.

Locations

Country	Name	City	State
Switzerland	Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of recurrent pleural effusions after chest tube removal	Evaluation of recurrent pleural effusion after chest tube removal	up to 6 weeks postoperative
Primary	Pain scores (VAS-Score)	Evaluation of Pain Scores after Chest tube removal	postoperative Period until 3 hours after Chest tube removal
Primary	Time Point of chest tube removal	postoperative day of chest tube removal	Postoperative, expected to be up to 1 week after surgery
Secondary	Patient discharge	Time Point of Patient discharge	At time of discharge, on average 4-7 days