Gravity- Versus Suction-driven Large Volume Thoracentesis

NCT03591952 | Completed

• 1 other identifier: 180339
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracentesis is a very common procedure, rarely associated with severe complications. One relatively common complication is chest discomfort, which is most of the time felt to be secondary to negative pleural pressures generated during the procedure. While most proceduralists use suction to drain the pleural fluid, some drain effusions by gravity only. The investigators propose to evaluate whether gravity-driven thoracentesis results in less discomfort for patients than suction-drive thoracentesis.

Conditions

Pleural Effusion

Keywords

Thoracentesis

Outcome Measures

Primary Outcomes (1)

• Difference in post-procedure chest discomfort scores between control (suction) and intervention (gravity) groups

  As measured in millimeters along a 10 cm Visual Analog Scale (VAS). The estimated minimal clinically important difference is 15 mm. Descriptive statistics including means, standard deviations, and ranges will be presented. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity will be made. If necessary, data will be transformed using Box-Cox power transformation. Comparisons between groups, i.e. intervention versus (vs) control, will be made using the t-test or Wilcoxon Rank Sum test. Mixed model will be employed to assess the trend of pain score measured across pre-, intra-, and post-procedure.

  One-time assessment, 5 minutes after thoracentesis catheter is removed (on day 1)

Secondary Outcomes (6)

• Incidence of pneumothorax

  20 minutes after thoracentesis catheter is removed (on day 1)

• Incidence of clinically-significant re-expansion pulmonary edema

  20 minutes after thoracentesis catheter is removed (on day 1)

• Incidence of radiographically-apparent re-expansion pulmonary edema

  20 minutes after thoracentesis catheter is removed (on day 1)

• Volume of pleural fluid removed by the thoracentesis procedure

  Immediately after the thoracentesis catheter is removed, on day 1

• Improvement in dyspnea scores

  From 1 minute pre-procedure to 5 minutes after thoracentesis catheter is removed (on day 1)

Study Arms (2)

Suction

ACTIVE COMPARATOR

The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care.

Procedure: Suction-Driven Thoracentesis

Gravity

EXPERIMENTAL

The pleural fluid will be drained using gravity drainage to a bag positioned approximately 100 cm (approximately 40 inches) below the catheter entry point (see picture below) using the 40 inch tubing provided in the thoracentesis kit (CareFusion or Arrow).

Procedure: Gravity-Driven Thoracentesis

Interventions

Suction-Driven Thoracentesis PROCEDURE

Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.

Suction

Gravity-Driven Thoracentesis PROCEDURE

Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.

Gravity

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 interspace, while the patient sits upright.
• Age \> 18

You may not qualify if:

• Inability to provide informed consent
• Patient has already been enrolled in this study
• 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 on bedside pre-procedure ultrasound
• Inability to sit for the procedure

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Lentz RJ, Shojaee S, Grosu HB, Rickman OB, Roller L, Pannu JK, DePew ZS, Debiane LG, Cicenia JC, Akulian J, Walston C, Sanchez TM, Davidson KR, Jagan N, Ahmad S, Gilbert C, Huggins JT, Chen H, Light RW, Yarmus L, Feller-Kopman D, Lee H, Rahman NM, Maldonado F; Interventional Pulmonary Outcomes Group. The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial. Chest. 2020 Mar;157(3):702-711. doi: 10.1016/j.chest.2019.10.025. Epub 2019 Nov 9.

  PMID: 31711990 DERIVED

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Fabien Maldonado, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be randomly allocated into intervention (gravity-driven) and control (suction-driven) groups by opening an opaque study envelope just prior to starting the procedure containing group assignment. Participants will be blinded to the use of gravity VS. suction drainage to prevent knowledge of their group assignment from biasing their pain assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Allergy/Pulmonary & Critical Care Medicine

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 19, 2018
• Study Start: August 1, 2018
• Primary Completion: April 5, 2019
• Study Completion: September 12, 2019
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

US (1)