Thoracentesis QI Study

University of Minnesota (UMN)

Status: Completed

Conditions: Pleural Effusion

Treatments: Procedure: Manual aspiration; Procedure: Vacuum bottle drainage; Procedure: Wall suction

Study type: Interventional

Funder types: Other

Identifiers

NCT05424120

PACCS-2021-30297

Details and patient eligibility

About

Researchers will compare 3 standard of care methods of pleural fluid drainage during therapeutic thoracentesis. Patients are randomized to manual aspiration, vacuum bottle drainage or wall suction methods. Primary outcome is procedural time with secondary outcomes of pain and dyspnea scores.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18
• Evidence of pleural effusion on imaging
• Clinical indication for thoracentesis

Exclusion criteria

• Age <18
• Standard contraindication for thoracentesis procedure
• Patients on positive pressure ventilation
• Patients who have opted out of research in EPIC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Manual aspiration

Active Comparator group

Description:

pleural fluid is drained using a standard thoracentesis kit and via a syringe and three-way stopcock

Treatment:

Procedure: Manual aspiration

Wall suction

Active Comparator group

Description:

pleural fluid is drained using a standard thoracentesis kit and by attaching tubing to wall suctioning set at -50 mmHg continuously

Treatment:

Procedure: Wall suction

Vacuum bottle drainage

Active Comparator group

Description:

pleural fluid is drained using a standard thoracentesis kit and tubing that attaches to a glass vacuum container

Treatment:

Procedure: Vacuum bottle drainage