GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05131945
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact	Horianna Grosu, MD
Phone	(713) 745-2261
Email	hbgrosu@mdanderson.org
Status	Recruiting
Phase	N/A
Start date	December 10, 2018
Completion date	August 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms