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

NCT ID: NCT03394872

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-08-30

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.

Conditions

Respiration, Artificial; Pleural Effusion; Ultrasonography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Drainage of the pleural effusion

Intervention Type: PROCEDURE

Interventions

Drainage of the pleural effusion

Intervention Type: PROCEDURE

Other Intervention Names

Thoracic Ultrasonography performed by USG certificated intensivist to the all subjects included in the study before 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Begum Ergan

Staff pulmonologist and intensivist in Department Pulmonary and Critical Care Medicine in Dokuz Eylul Universty Hospital, Dokuz Eylul University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barış Yılmaz, MD

Role: STUDY_CHAIR

Fellow of Critical Care in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University

Tuğçe Yılmaz, MD

Role: STUDY_CHAIR

Fellow of Critical Care in Department of Neurology and Critical Care Medicine in Dokuz Eylül University

Begum Ergan, MD

Role: PRINCIPAL_INVESTIGATOR

Staff in Department of Pulmonary and Critical Care Medicine in Dokuz Eylül University

Necati Gokmen, MD

Role: STUDY_DIRECTOR

Staff in Department of Anesthesiology and Critical Care Medicine in Dokuz Eylül University

Kutlay Aydin, MD

Role: STUDY_CHAIR

Fellow of Critical Care in Department of Anesthsiology and Critical Care Medicine in Dokuz Eylül University

Other Identifiers

2496-GOA

Identifier Type: -

Identifier Source: org_study_id