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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?

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03093610
Collaborator
(none)
304
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
13.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Traditional
  • Procedure: Test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
304 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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/24hGroup 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 (Care Provider)
Masking Description:
The operating surgeon does not know to which group the Patient will be attributed to.
Primary Purpose:
Prevention
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?
Actual Study Start Date :
May 31, 2019
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Traditional

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of recurrent pleural effusions after chest tube removal [up to 6 weeks postoperative]

    Evaluation of recurrent pleural effusion after chest tube removal

  2. Pain scores (VAS-Score) [postoperative Period until 3 hours after Chest tube removal]

    Evaluation of Pain Scores after Chest tube removal

  3. Time Point of chest tube removal [Postoperative, expected to be up to 1 week after surgery]

    postoperative day of chest tube removal

Secondary Outcome Measures

  1. Patient discharge [At time of discharge, on average 4-7 days]

    Time Point of Patient discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Lobectomy/ Bilobectomy

  • Segmentectomy

  • Signed consent

  • Age of majority

Exclusion criteria:

  • Pneumonectomy

  • Atypical resections

  • Empyema

  • Pleural effusion (not related to surgery)

  • Pleurodesis

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bern University Hospital Bern Switzerland 3007

Sponsors and Collaborators

  • University Hospital Inselspital, Berne

Investigators

  • Study Director: Gregor Kocher, Deputy Chief, Department of general thoracic surgery, Bern University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT03093610
Other Study ID Numbers:
  • 14032017
First Posted:
Mar 28, 2017
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pleural Effusion
Recurrence

Study Results

No Results Posted as of Sep 28, 2020