Lung Pathologies of Unclear Etiology
Conditions
Brief summary
The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.
Detailed description
Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.
Interventions
PROCEDUREEarly postoperative day 0 (POD 0) chest tube removal.
Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).
PROCEDUREChest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Prospective randomization of patients after minor thoracic operations into two different groups. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow \<20 mL/ min on digital suction device) but already in the operating room after wound closure. If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1. In the control group, the chest tube gets removed according to the investigators' traditional standard protocol not earlier than on postoperative day.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy) 2. Thoracoscopic pleural biopsy 3. Signed consent 4. Age of majority
Exclusion criteria
1. Anatomical resection 2. Empyema 3. Pleural effusion 4. Pleurodesis 5. Vulnerable persons (Pregnant women, Children and adolescents)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Pneumothorax requiring chest tube reinsertion | Pneumothorax 2 hours after chest tube removal between postoperative day 0 and 30 (POD 0 - 30) | Number of patients with pneumothorax requiring chest tube reinsertion after removal of initial chest tube |
| 2. Pleural effusion requiring thoracocentesis | Pleural effusion 2 hours after chest tube removal between POD 0 and 30 | Number of patients with pleural effusion requiring thoracocentesis after removal of first chest tube |
| 3. Prolonged air leak > 5 days | Chest tube removal between POD 6 and 30 | Number of patients with persisting air leak longer than 5 days |
| 4. Re-admission or reoperation due to pleural complication | Up to 1 month after first operation | Number of patients re-admitted to a hospital after first hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1. Cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) | Up to 1 month after initial operation | Number of patients with cardiopulmonary complications (Pneumonia, Atrial fibrillation, ARDS) after operation |
| 2. Re-operation | Up to 1 month after initial operation | Number of patients requiring a re-operation after initial operation |
| 3. Length of drainage (days) | Up to 1 month after initial operation | Average of time with chest tube in site |
| 4. Length of stay (days) | Up to 1 month after initial operation | Average of time in hospital |
Countries
Switzerland
Contacts
CONTACTPatrick Dorn, PD
STUDY_DIRECTORPatrick Dorn, PD
Chief, Department of General Thoracic Surgery, Inselspital
Outcome results
None listed