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

Ultrasonography Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394872
• Other study ID #: 2496-GOA
• Status: Completed
• Phase: N/A
• First received: December 19, 2017
• Last updated: January 8, 2018
• Start date: May 1, 2016
• Est. completion date: August 30, 2017

Study information

• Verified date: January 2018
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Respiration, Artificial
• Ultrasonography

Intervention

Procedure:
• Drainage of the pleural effusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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