TY - JOUR
T1 - The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications
T2 - The GRAVITAS Multicenter Randomized Controlled Trial
AU - Interventional Pulmonary Outcomes Group
AU - Lentz, Robert J.
AU - Shojaee, Samira
AU - Grosu, Horiana B.
AU - Rickman, Otis B.
AU - Roller, Lance
AU - Pannu, Jasleen K.
AU - DePew, Zachary S.
AU - Debiane, Labib G.
AU - Cicenia, Joseph C.
AU - Akulian, Jason
AU - Walston, Charla
AU - Sanchez, Trinidad M.
AU - Davidson, Kevin R.
AU - Jagan, Nikhil
AU - Ahmad, Sahar
AU - Gilbert, Christopher
AU - Huggins, John T.
AU - Chen, Heidi
AU - Light, Richard W.
AU - Yarmus, Lonny
AU - Feller-Kopman, David
AU - Lee, Hans
AU - Rahman, Najib M.
AU - Maldonado, Fabien
N1 - Funding Information:
Author contributions: R. J. L. and F. M. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any adverse effects. R. J. L. F. M. N. M. R. L. Y. and O. B. R. were responsible for study concept and design; R. J. L. S. S. H. B. G. O. B. R. L. R. J. K. P. Z. S. D. L. G. D. J. C. C. J. A. C. W. T. M. S. K. R. D. N. J. S. A. L. Y. F. M. D. F.-K. and H. L. were responsible for acquisition of data; R. J. L. F. M. N. M. R. H. C. R. W. L. C. G. J. T. H. S. S. H. G. B. J. K. P. J. C. C. L. Y. D. F.-K. and H. L. analyzed and interpreted the data; and R. J. L. F. M. N. M. R. and L. Y. drafted the manuscript. All authors participated in critical revision of the manuscript for important intellectual content and provided final approval to submit the final version of the manuscript and have agreed to be accountable for all aspects of the work. Financial/nonfinancial disclosures: None declared. Other contributions: The authors acknowledge nonfinancial support from the Interventional Pulmonary Outcomes Group in the design and conduct of this trial. Additional information: The e-Tables and e-Figures can be found in the Supplemental Materials section of the online article.
PY - 2020/3
Y1 - 2020/3
N2 - 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.
AB - 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.
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U2 - 10.1016/j.chest.2019.10.025
DO - 10.1016/j.chest.2019.10.025
M3 - Article
C2 - 31711990
AN - SCOPUS:85079856638
VL - 157
SP - 702
EP - 711
JO - Chest
JF - Chest
SN - 0012-3692
IS - 3
ER -