Pulmonary Edema Clinical Trial
Official title:
GRAvity- Versus Wall Suction-drIven Large Volume Thoracentesis: a rAndomized Controlled Study (GRAWITAS Study)
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.
Status | Recruiting |
Enrollment | 228 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. Referral to pulmonary services for large-volume thoracentesis 2. Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of: 1. Chest radiograph: effusion filling = 1/3 the hemithorax, OR 2. 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. 3. Age >/= 18 Exclusion criteria: 1. Inability to provide informed consent 2. Study subject has any disease or condition that interferes with safe completion of the study including: 1. Coagulopathy, with criteria left at the discretion of the operator 2. 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 3. Pleural effusion is smaller than expected on bedside pre-procedure ultrasound 4. Referral is for diagnostic thoracentesis only 5. Presence of more than minimal septations and/or loculations( more than 3) on bedside pre-procedure ultrasound 6. Inability to sit for the procedure 7. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The overall procedural chest pain questionnaire | The Global Pain Score will be determined at 5 minutes post-procedure using a VAS 0-100 and represents the pain experienced by the patient during the entire procedure from the beginning to the 5-minute post-procedure assessment | through study completion, an average of 1 year |
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