Robert J Lentz1, Samira Shojaee2, Horiana B Grosu3, Otis B Rickman4, Lance Roller5, Jasleen K Pannu6, Zachary S DePew7, Labib G Debiane8, Joseph C Cicenia9, Jason Akulian10, Charla Walston4, Trinidad M Sanchez2, Kevin R Davidson2, Nikhil Jagan7, Sahar Ahmad11, Christopher Gilbert12, John T Huggins13, Heidi Chen14, Richard W Light5, Lonny Yarmus15, David Feller-Kopman15, Hans Lee15, Najib M Rahman16, Fabien Maldonado17. 1. Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN; Department of Veterans Affairs Medical Center, Nashville, TN. 2. Division of Pulmonary Disease and Critical Care Medicine, Department of Medicine, Virginia Commonwealth University, Richmond, VA. 3. Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. 4. Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN. 5. Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN. 6. Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, The Ohio State University Wexner Medical Center, Columbus, OH. 7. Division of Pulmonary, Critical Care, and Sleep Medicine, Creighton University School of Medicine, Omaha, NE. 8. Division of Pulmonary and Critical Care Medicine, Department of Medicine, Henry Ford Health System, Detroit, MI. 9. Department of Pulmonary Medicine, Cleveland Clinic, Cleveland, OH. 10. Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC. 11. Division of Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Stony Brook University Hospital, Stony Brook, NY. 12. Division of Thoracic Surgery and Interventional Pulmonology, Swedish Cancer Institute, Seattle, WA. 13. Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC. 14. Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN. 15. Section of Interventional Pulmonology, Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD. 16. Oxford Centre for Respiratory Medicine, Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK. 17. Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN; Department of Thoracic Surgery, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: fabien.maldonado@vumc.org.
Abstract
BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergoactive aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications. CONCLUSIONS:Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.
RCT Entities:
BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This trial investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P < .001). There were no serious complications. CONCLUSIONS: Thoracentesis via active aspiration and gravity drainage are both safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.
Authors: Greta Jean Dahlberg; Fabien Maldonado; Heidi Chen; Otis Rickman; Lance Roller; Charla Walston; James Katsis; Robert Lentz Journal: BMJ Open Respir Res Date: 2020-12