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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?

NCT ID: NCT03093610

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion Recurrence Pulmonary Resection Chest Tube Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers
The operating surgeon does not know to which group the Patient will be attributed to.

Study Groups

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Traditional

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

Group Type ACTIVE_COMPARATOR

Traditional

Intervention Type PROCEDURE

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

Test group

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.

Group Type ACTIVE_COMPARATOR

Test

Intervention Type PROCEDURE

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

Interventions

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Traditional

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

Intervention Type PROCEDURE

Test

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pneumonectomy
* Atypical resections
* Empyema
* Pleural effusion (not related to surgery)
* Pleurodesis
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Dorn

Role: STUDY_DIRECTOR

Chief, Department of General Thoracic Surgery, Bern University Hospital

Locations

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Bern University Hospital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 23872457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25979532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24158313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18242249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12437253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12174980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22219425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11053819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13984113 (View on PubMed)

Other Identifiers

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14032017

Identifier Type: -

Identifier Source: org_study_id