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Completed

NCT Number: NCT03394872

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Drainage of the pleural effusion

Procedure

Other names: Thoracic Ultrasonography performed by USG certificated intensivist to the all subjects included in the study before drainage

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2018
Registry last updated
Jan 9, 2018

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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