A Phase 4 interventional study of Reg Pressure and Unreg Pressure in Lung Resection, sponsored by Yale University. Completed at 5 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-06-26.
Sponsored by Yale University · Phase 4, Interventional, and Supportive care
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
This study is a prospective, multi-center randomized clinical trial at 6 sites. Pre-operative evaluation and the decision for surgical intervention will proceed as currently performed at each center. That is, neither inclusion in nor exclusion from this study will affect the plan of care for patients other than the approach to chest tube management, which is determined by randomization among 4 methods that are in common clinical use. Each enrolled patient will be randomized to either regulated pleural pressure using the Thopaz+ digital chest drainage device or unregulated pleural pressure using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution) and also randomized to either active suction (-20 cm H2O) or passive drainage.
Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Regulated pleural pressure with active suction
Other: Reg Pressure · Other: Active Suction (Dig)
Regulated pleural pressure with passive drainage
Other: Reg Pressure · Other: Passive Drainage (Dig)
Unregulated pleural pressure with active suction
Other: Unreg Pressure · Other: Active Suction (Trad)
Unregulated pleural pressure with passive drainage
Other: Unreg Pressure · Other: Passive Drainage (Trad)
Regulated Suction using the Thopaz+ digital chest drainage device
Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)
Thopaz+ digital chest drainage device set at -20cmH2O at the patient
Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
Thopaz+ digital chest drainage device set at -8cmH2O at the patient ("physiologic")
Pleur-Evac, Atrium-Maquet or similar set by gravity ("water-seal')
Duration of air leak
Duration until there is no clinically significant air leak by standard criteria (no bubbles during coughing with a traditional device and a ≥6 hour period with no spikes \>80 ml/min and an air flow ≤30 ml/min during passive drainage or ≤50 ml/min during active suction)
Time frame: up to 7 days
Time till chest tube removal
Duration of time till chest tube is removed. Chest tube will be removed when resolution of air leak and fluid drainage \<= 400 ml/day
Time frame: up to 7 days
Duration of hospital stay
How long is the total hospital stay
Time frame: up to 7 days
Amount of fluid drained
How much fluid is drained while the chest tube is in place
Time frame: up to 7 days
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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