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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Pleural Effusion; Respiration, Artificial
• Intervention / Treatment: Procedure: Drainage of the pleural effusion

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Critical care patients on mechanical ventilation due to acute respiratory failure and have significant pleural effusion who had drainage plan according to İCU protocols decided by primary physician were enrolled for the study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Procedure: Drainage of the pleural effusion; Other Names: Thoracic Ultrasonography performed by USG certificated intensivist to the all subjects included in the study before drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between estimated and drained effusion volume	Volume of the effusion estimated and drained was recorded (mL)	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.
Change in Lung mechanics	Dynamic Compliance (mL/cmH2O)	1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
Change in Oxygenation	PaO2/FiO2 (fraction of inspired oxygen)	1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Study Chair: Barış Yılmaz, MD, Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University; Study Chair: Tuğçe Yılmaz, MD, Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University; Principal Investigator: Begum Ergan, MD, Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University; Study Director: Necati Gokmen, MD, Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül University; Study Chair: Kutlay Aydin, MD, Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): August 30, 2017

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Drainage; Mechanical Ventilation; Ultrasonography; Pleural effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: 2496-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No