Lung Cancer
Conditions
Keywords
chest tube, lung resection, patient satisfaction, mobility
Brief summary
This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay. Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period. Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world.
Interventions
Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1. On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients
Sponsors
The Leeds Teaching Hospitals NHS Trust
The University of Hong Kong
Yale University
Ospedali Riuniti Ancona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to read, understand, and provide written Informed Consent 2. Age range of 18-90 years 3. Patients undergoing a segmentectomy, lobectomy, or bilobectomy. Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable.
Exclusion criteria
1. Patients unstable enough to require ICU care upon completion of the resection 2. Redo thoracotomies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of chest tubes | date of chest tube removal |
Secondary
| Measure | Time frame |
|---|---|
| total distance of ambulation in the first 48 postoperative hours | 48 hours after surgery |
Other
| Measure | Time frame |
|---|---|
| overall patient satisfaction with chest drainage system. | 48 hours after surgery |
Countries
Italy
Outcome results
None listed