Chest Tubes, Pleural Effusion, Video Assisted Thoracic Surgery
Conditions
Brief summary
The aim of the study is to evaluate efficacy and safety of Smart Coaxial drain (Redax TM, Poggio Rusco, Mantova, Italia) in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's comfort in Uniportal- and Biportal-VATS upper lobectomies. In particular, to evaluate in Uniportal-VATS upper lobectomies the efficacy and safety of smart coaxial drains compared with standard silicone chest tubes.
Detailed description
At the end of lung surgery, usually surgeons placed one or more chest tubes. There are several types of chest tubes and the type used by surgeons depends on centre avaiability/ local practice or surgeon choice etc...Coaxial smart drains are used in clinical practice since several years in Thoracic Surgery. In thoracoscopic (VATS) surgery usually only one chest tube is placed. In this study, we evaluate the efficacy of placement of 28Fr coaxial smart drain chest tube versus 28 Fr standard chest tube after Uniportal- or Biportal-VATS upper lobectomies in terms of total amount of effusion drained, incidence of residual effusion at Chest X-Ray and patient's confort.
Interventions
PROCEDURE28Fr coaxial smart drain chest tube
To evaluate the efficacy of one 28Fr chest tube (coaxial smart drain versus standard chest tube according to local practice, types of drainage availability in each centre, surgeon's choice etc) after Uniportal- or Biportal-VATS upper lobectomies.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS
Exclusion criteria
* Patients undergone open surgery * Patients undergone middle or lower lobectomies * Patients undergone chest wall/or wedge resections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| subcutaneous emphysema 3 | At 72 hours after surgery | incidence of subcutaneous emphysema |
| Fluid output 3 | At 72 hours from surgery | Total fluid amount |
| Fluid output 4 | At 96 hours from surgery | Total fluid amount |
| Residual pleural effusion at chest X-Ray | 72 hours after surgery | Residual pleural effusion at chest X-Ray before chest tube removal. The entity of pleural effusion is measured as intercostal spaces, counted on posterior costal arches |
| subcutaneous emphysema 1 | At 24 hours after surgery | incidence of subcutaneous emphysema |
| subcutaneous emphysema 2 | At 48 hours after surgery | incidence of subcutaneous emphysema |
| Fluid output 1 | At 24 hours from surgery | Total fluid amount |
| Fluid output 2 | At 48 hours from surgery | Total fluid amount |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain related to chest tube 1 | At 24 hours after surgery | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\>4 and \<10 indicates moderate to severe pain) |
| Pain related to chest tube 2 | At 48 hours after surgery | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\>4 and \<10 indicates moderate to severe pain) |
| Pain related to chest tube 3 | At 72 hours after surgery | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\>4 and \<10 indicates moderate to severe pain) |
| Pain related to chest tube 4 | At 96 hours after surgery | Pain measured in each postoperative day on VAS scale (Visual Analogue Scale, range:from 0 to 10; VAS\>4 and \<10 indicates moderate to severe pain) |
| Tube obstruction | during chest tube removal procedure | tube obstructed by blood clots |
Countries
Italy
Outcome results
None listed