Clinical trial NCT03394872: Impact of Draining Significant Effusion on Gas Exchange and Lung Mechanics in Patient Under Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration, Artificial
Pleural Effusion
Ultrasonography
Keywords: Pleural effusion
Mechanical Ventilation
Ultrasonography
Drainage
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between estimated and drained effusion volume
timeFrame: 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.
measure: Change in Lung mechanics
timeFrame: 1- Dynamic Compliance just before the drainage 2- Dynamic Compliance just after the drainage is terminated up to 30 days after procedure
measure: Change in Oxygenation
timeFrame: 1- PaO2/FiO2 just before the drainage 2- PaO2/FiO2 just after the drainage is terminated up to 30 days after procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
name: Barış Yılmaz, MD
role: STUDY_CHAIR
affiliation: Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University
name: Tuğçe Yılmaz, MD
role: STUDY_CHAIR
affiliation: Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University
name: Begum Ergan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül University
name: Necati Gokmen, MD
role: STUDY_DIRECTOR
affiliation: Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University
name: Kutlay Aydin, MD
role: STUDY_CHAIR
References: