GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GR… (NCT05131945) | Clinical Trial Compass
CompletedNot Applicable
GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a RAndomized Controlled Study (GRAWITAS Study)
United States79 participantsStarted 2018-12-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
The overall procedural chest pain questionnaire
Timeframe: through study completion, an average of 1 year