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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Edema; Pleural Effusions, Chronic; Thoracentesis
• Intervention / Treatment: Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis

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

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Horianna Grosu, MD; Phone Number: (713) 745-2261; Email: hbgrosu@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77051
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Horiana Grosu, MD; Phone Number: 713-745-2261; Email: hbgrosu@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

1. Referral to pulmonary services for large-volume thoracentesis

2. Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:

   1. Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
   2. CT-scan: maximum AP depth of the effusion ≥ 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung completely surrounded by effusion, OR Ultrasound: effusion spanning at least three interspaces, with depth of 3 cm or greater in at least one intercostal space, while the patient sits upright.
3. Age >/= 18

Exclusion criteria:

1. Inability to provide informed consent

2. Study subject has any disease or condition that interferes with safe completion of the study including:

   1. Coagulopathy, with criteria left at the discretion of the operator
   2. Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians
3. Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
4. Referral is for diagnostic thoracentesis only
5. Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
6. Inability to sit for the procedure
7. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall procedural chest pain questionnaire	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Horianna Grosu, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center website

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2018
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Pulmonary Edema; Pleural Effusion
• Other Study ID Numbers: 2018-0654; NCI-2021-13202 (Other Identifier: Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No