Lung Resection
Conditions
Keywords
Chest tube
Brief summary
A 2 x 2 randomized study testing active versus passive drainage and regulated versus unregulated pleural pressure in patients undergoing anatomic lung resection
Detailed description
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.
Interventions
OTHERReg Pressure
Regulated Suction using the Thopaz+ digital chest drainage device
OTHERUnreg Pressure
Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)
OTHERActive Suction (Dig)
Thopaz+ digital chest drainage device set at -20cmH2O at the patient
OTHERActive Suction (Trad)
Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
OTHERPassive Drainage (Dig)
Thopaz+ digital chest drainage device set at -8cmH2O at the patient (physiologic)
OTHERPassive Drainage (Trad)
Pleur-Evac, Atrium-Maquet or similar set by gravity (water-seal')
Sponsors
Medela AG
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Able and willing to read, understand, and provide written consent * Age 18-90 * Undergoing a segmentectomy, lobectomy, or bilobectomy (including sleeve resection). Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable
Exclusion criteria
* Patients unstable enough to require ICU care for hemodynamic or respiratory problems during the first 7 days postoperatively. Patients admitted to the ICU for other reasons (e.g. bed availability, institutional norm, routine monitoring etc.) should NOT be excluded * Patients undergoing non-anatomic lung resection only (i.e. wedge resection) * Patients undergoing anatomic lung resection for bullous disease, lung abscess or bronchiectasis. * Patients undergoing pneumonectomy or completion pneumonectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of air leak | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time till chest tube removal | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay | up to 7 days | How long is the total hospital stay |
| Amount of fluid drained | up to 7 days | How much fluid is drained while the chest tube is in place |
Countries
United States
Outcome results
None listed