Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation

Overview

Patients with acute respiratory failure (ARF) who were receiving mechanical ventilator support, had significant pleural effusion (both transudates and exudates) and drainage plan were evaluated. Decision to drain, timing and duration of drainage were made by primary physician according to the intensive care unit (ICU) protocols.The estimated amount of effusion (mL) was calculated as the maximum pleura-lung distance (mm) x 20 and significant effusion is accepted as ≥ 800 mL according to thoracic ultrasonography (USG) performed by the intensivist. The amount of effusion drained, mechanical ventilator parameters, arterial blood gas results and hemodynamic data were recorded before, at the 1st hour and at the end of drainage up to 30 days after drainage.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 30, 2017

Interventions

  • Procedure: Drainage of the pleural effusion

Arms, Groups and Cohorts

  • Drainage group
    • Patients under mechanical ventilator support due to acute respiratory failure who had significant pleural effusion and drainage plan according to the intensive Care Unit (ICU) protocols decided by primary physician

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between estimated and drained effusion volume
    • Time Frame: 1- Estimated effusion volume just before the drainage (by ultrasonography calculated as described in brief summary) 2- Drained effusion volume just after the drainage is terminated up to 30 days after procedure.
    • Volume of the effusion estimated and drained was recorded (mL)
  • Change in Lung mechanics
    • Time Frame: 1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
    • Dynamic Compliance (mL/cmH2O)
  • Change in Oxygenation
    • Time Frame: 1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
    • PaO2/FiO2 (fraction of inspired oxygen)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients on mechanical ventilation due to acute respiratory failure
  • Estimated effusion > 800 ml according to USG
  • Have drainage plan according to ICU protocols decided by primary physician

Exclusion Criteria

  • Have absolute drainage indication (empyema, hemothorax or chylothorax)
  • predicted duration of mechanical ventilation less than 72 hours
  • contraindications to drainage,
  • underlying disease, which prevents lung expansion (chest deformity, central atelectasis)
  • malignant effusions

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dokuz Eylul University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Begum Ergan, Staff pulmonologist and intensivist in Department Pulmonary and Critical Care Medicine in Dokuz Eylul Universty Hospital, Dokuz Eylul University – Dokuz Eylul University
  • Overall Official(s)
    • Barış Yılmaz, MD, Study Chair, Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
    • Tuğçe Yılmaz, MD, Study Chair, Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University
    • Begum Ergan, MD, Principal Investigator, Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
    • Necati Gokmen, MD, Study Director, Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül University
    • Kutlay Aydin, MD, Study Chair, Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University

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