NCT05131945

GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure. This study is a multicenter, single-blinded, randomized controlled trial designed to compare chest discomfort between gravity-driven and wall suction-driven therapeutic thoracentesis. Patients will be stratified by study centers, and randomly assigned to intervention and control arms; and will remain blinding to their group assignment during the procedure.

Detailed description

Aims and Objectives: The primary objective of this study is to compare gravity-driven versus wall suction-driven large volume therapeutic thoracentesis on the development of chest discomfort during the procedure. Expected Outcomes: We anticipate that gravity driven therapeutic thoracentesis will result in improved clinical outcomes compared to wall suction driven thoracentesis, defined by less chest discomfort throughout the procedure as measured at 5 minutes post-procedure (primary endpoint). Primary endpoint: The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment ("On average, how much discomfort have you felt during the procedure?"). The primary endpoint is defined as the overall procedural chest pain scored 5 minutes following the procedure. This study is a randomized controlled trial designed to compare the changes of chest pain scores between gravity-driven therapeutic thoracentesis and wall suction-driven thoracentesis. The estimated minimal clinically important difference of the change is 10. Secondary endpoints: 1. Duration of procedure timed from the beginning of fluid drainage to catheter removal. 2. Differences in narcotics used after the procedure. 3. Incidence of pneumothorax detected on the post procedural CXR 4. Incidence of clinically apparent re-expansion pulmonary edema 5. Incidence of radiographically apparent re-expansion pulmonary edema detected on the post procedural CXR

Conditions

• Thoracentesis
• Pleural Effusions, Chronic
• Pulmonary Edema

Interventions

Type	Name	Description
OTHER	Standard Suction Thoracentesis	a procedure that removes excess fluid from the space in between your lungs and chest wall
OTHER	Gravity Thoracentesis	a procedure that removes excess fluid from the space in between your lungs and chest wall

Timeline

• Start date: 2018-12-10
• Primary completion: 2024-09-10
• Completion: 2024-09-10
• First posted: 2021-11-23
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States