An interventional study of Standard Suction Thoracentesis and Gravity Thoracentesis in Thoracentesis, Pleural Effusions, Chronic and Pulmonary Edema, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Other
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.
Aims and Objectives:
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.
Expected Outcomes:
We anticipate that gravity driven therapeutic thoracentesis will result in improved clinical outcomes compared to wall suction driven thoracentesis, defined by less chest discomfort throughout the procedure as measured at 5 minutes post-procedure (primary endpoint).
Primary endpoint:
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 ("On average, how much discomfort have you felt during the procedure?"). The primary endpoint is defined as the overall procedural chest pain scored 5 minutes following the procedure.
This study is a randomized controlled trial designed to compare the changes of chest pain scores between gravity-driven therapeutic thoracentesis and wall suction-driven thoracentesis. The estimated minimal clinically important difference of the change is 10.
Secondary endpoints:
335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.
This study's enrollment of 79 is above the median of 62 across 220 interventional studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of a symptomatic moderate or large free-flowing (non-septated) pleural effusion on the basis of:
Exclusion criteria:
Study subject has any disease or condition that interferes with safe completion of the study including:
treatment techniques suction is a standard of care and used for draining fluid around the lung.
Other: Standard Suction Thoracentesis · Other: Gravity Thoracentesis
treatment techniques (gravity ) is a standard of care and used for draining fluid around the lung.
Other: Standard Suction Thoracentesis · Other: Gravity Thoracentesis
a procedure that removes excess fluid from the space in between your lungs and chest wall
a procedure that removes excess fluid from the space in between your lungs and chest wall
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
Time frame: through study completion, an average of 1 year
Plan to share: No
Ran from Dec 2018 to primary completion in Sep 2024, 69 months.
Of 71 non-industry interventional studies with no phase under Pleural Effusion, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's 69 months is above that.
Counting every sponsor, half of 73 studies reached it within 30 months; a quarter within 18 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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