Reg Pressure
OtherRegulated Suction using the Thopaz+ digital chest drainage device
NCT Number: NCT02282462
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
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Notify Me18 year–90 year
All sexes
Interventional
Phase 4
Yale University, New Haven, Connecticut, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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')
Time frame: up to 7 days
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
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
How long is the total hospital stay
Time frame: up to 7 days
How much fluid is drained while the chest tube is in place
Yale University
Other
A Randomized Comparison of Active Suction vs. Passive Chest Tube Drainage and Regulated and Unregulated Pleural Pressure After Anatomic Lung Resection
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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