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OpenTrials
Completed

NCT Number: NCT03093610

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?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bern University Hospital

Bern, 3007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

traditional

Procedure

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

Test

Procedure

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

Primary outcomes

  1. Number of recurrent pleural effusions after chest tube removal

    Time frame: up to 6 weeks postoperative

    Evaluation of recurrent pleural effusion after chest tube removal

  2. Pain scores (VAS-Score)

    Time frame: postoperative Period until 3 hours after Chest tube removal

    Evaluation of Pain Scores after Chest tube removal

  3. Time Point of chest tube removal

    Time frame: Postoperative, expected to be up to 1 week after surgery

    postoperative day of chest tube removal

Secondary outcomes

  1. Patient discharge

    Time frame: At time of discharge, on average 4-7 days

    Time Point of Patient discharge

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2017
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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