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?

NCT03093610 | Completed DMC

• 1 other identifier: 14032017
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusion Recurrence; Pulmonary Resection; Chest Tube Management

Outcome Measures

Primary Outcomes (3)

• Number of recurrent pleural effusions after chest tube removal

  Evaluation of recurrent pleural effusion after chest tube removal

  up to 6 weeks postoperative

• Pain scores (VAS-Score)

  Evaluation of Pain Scores after Chest tube removal

  postoperative Period until 3 hours after Chest tube removal

• Time Point of chest tube removal

  postoperative day of chest tube removal

  Postoperative, expected to be up to 1 week after surgery

Secondary Outcomes (1)

• Patient discharge

  At time of discharge, on average 4-7 days

Study Arms (2)

Traditional

ACTIVE COMPARATOR

The chest tube in the traditional Group will be managed according to the current Guidelines of the investigators' department.

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.

Procedure: Test

Interventions

Traditional PROCEDURE

Removal of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less.

Traditional

Test PROCEDURE

Removal of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Bern University Hospital

Bern, 3007, Switzerland

Location

Related 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.

  PMID: 23872457 BACKGROUND

• 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.

  PMID: 25979532 BACKGROUND

• 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.

  PMID: 24158313 BACKGROUND

• 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.

  PMID: 18242249 BACKGROUND

• 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.

  PMID: 12437253 BACKGROUND

• 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.

  PMID: 12174980 BACKGROUND

• 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.

  PMID: 22219425 BACKGROUND

• 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.

  PMID: 11053819 BACKGROUND

• 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.

  PMID: 13984113 BACKGROUND

Study Officials

• Patrick Dorn

  Chief, Department of General Thoracic Surgery, Bern University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The operating surgeon does not know to which group the Patient will be attributed to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: May 31, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 30, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)