The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.

Aged Chest Pain / epidemiology Drainage / methods Dyspnea / epidemiology Female Gravitation Humans Male Middle Aged Operative Time Pain, Procedural / epidemiology Pleural Effusion / surgery Pneumothorax / epidemiology Postoperative Complications / epidemiology Pulmonary Edema / epidemiology Single-Blind Method Suction / methods Thoracentesis / methods

gravity pleural effusion suction thoracentesis

Journal

Chest

ISSN: 1931-3543

Titre abrégé: Chest

Pays: United States

ID NLM: 0231335

Informations de publication

Date de publication:
03 2020

Historique:

received: 14 09 2019

revised: 16 10 2019

accepted: 16 10 2019

pubmed: 13 11 2019

medline: 21 10 2020

entrez: 13 11 2019

Statut: ppublish

Résumé

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. 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. 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. 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. ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov.

Sections du résumé

BACKGROUND

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.

Identifiants

DOI: 10.1016/j.chest.2019.10.025 PMID: 31711990

pubmed: 31711990

pii: S0012-3692(19)34190-X

doi: 10.1016/j.chest.2019.10.025

pii:

doi:

Banques de données

ClinicalTrials.gov

['NCT03591952']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

702-711

Subventions

Organisme : Marie Curie

ID : MCCC-RP-14-A17178

Pays : United Kingdom

Commentaires et corrections

Type : CommentIn