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

Not Applicable

Recruiting

• Conditions: Pleural Effusions, Chronic; Pulmonary Edema; Thoracentesis
• Interventions: Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis

• Registration Number: NCT05131945
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-12-10
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-11-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1: Standard Suction Thoracentesis	Standard Suction Thoracentesis	treatment techniques suction is a standard of care and used for draining fluid around the lung.
Group 1: Standard Suction Thoracentesis	Gravity Thoracentesis	treatment techniques suction is a standard of care and used for draining fluid around the lung.
Group 2: Gravity Thoracentesis.	Standard Suction Thoracentesis	treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung.
Group 2: Gravity Thoracentesis.	Gravity Thoracentesis	treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung.

Primary Outcome Measures

Name	Time	Method
The overall procedural chest pain questionnaire	through study completion, an average of 1 year	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States