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

NCT05131945 | Completed

• 2 other identifiers: 2018-0654NCI-2021-13202
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracentesis; Pleural Effusions, Chronic; Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1: Standard Suction Thoracentesis

EXPERIMENTAL

treatment techniques suction is a standard of care and used for draining fluid around the lung.

Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis

Group 2: Gravity Thoracentesis.

EXPERIMENTAL

treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung.

Other: Standard Suction Thoracentesis; Other: Gravity Thoracentesis

Interventions

Standard Suction Thoracentesis OTHER

a procedure that removes excess fluid from the space in between your lungs and chest wall

Group 1: Standard Suction Thoracentesis; Group 2: Gravity Thoracentesis.

Gravity Thoracentesis OTHER

a procedure that removes excess fluid from the space in between your lungs and chest wall

Group 1: Standard Suction Thoracentesis; Group 2: Gravity Thoracentesis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral to pulmonary services for large-volume thoracentesis
• Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
• Chest radiograph: effusion filling ≥ 1/3 the hemithorax, OR
• 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.
• Age \>/= 18

You may not qualify if:

• Inability to provide informed consent
• Study subject has any disease or condition that interferes with safe completion of the study including:
• Coagulopathy, with criteria left at the discretion of the operator
• 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
• Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
• Referral is for diagnostic thoracentesis only
• Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound
• Inability to sit for the procedure
• Pregnancy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77051, United States

Location

Related Publications (1)

• Shojaee S, Pannu J, Yarmus L, Fantin A, MacRosty C, Bassett R Jr, Debiane L, DePew ZS, Faiz SA, Jimenez CA, Avasarala SK, Vakil E, DeMaio A, Bashoura L, Keshava K, Ferguson T, Adachi R, Eapen GA, Ost DE, Bashour S, Khan A, Shannon V, Sheshadri A, Casal RF, Evans SE, Pew K, Castaldo N, Balachandran DD, Patruno V, Lentz R, Pai C, Maldonado F, Roller L, Ma J, Zaveri J, Los J, Vaquero L, Ordonez E, Yermakhanova G, Akulian J, Burks C, Almario RR, Sauve M, Pettee J, Noor LZ, Arain MH, Grosu HB. Gravity- vs Wall Suction-Driven Large-Volume Thoracentesis: A Randomized Controlled Study. Chest. 2024 Dec;166(6):1573-1582. doi: 10.1016/j.chest.2024.05.046. Epub 2024 Jul 18.

  PMID: 39029784 DERIVED

Related Links

• M D Anderson Cancer Center website

MeSH Terms

Conditions

Pleural Effusion; Bronchiolitis Obliterans Syndrome; Pulmonary Edema

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Horianna Grosu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 23, 2021
• Study Start: December 10, 2018
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)