Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

Pleural Effusion Clinical Trial

Official title:

Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036667
• Other study ID #: ID 2388
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Tubes
• Pleural Effusion
• Video Assisted Thoracic Surgery

Intervention

Procedure:
• 28Fr "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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid output 1	Total fluid amount	At 24 hours from surgery
Primary	Fluid output 2	Total fluid amount	At 48 hours from surgery
Primary	Fluid output 3	Total fluid amount	At 72 hours from surgery
Primary	Fluid output 4	Total fluid amount	At 96 hours from surgery
Primary	Residual pleural effusion at chest X-Ray	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	72 hours after surgery
Primary	subcutaneous emphysema 1	incidence of subcutaneous emphysema	At 24 hours after surgery
Primary	subcutaneous emphysema 2	incidence of subcutaneous emphysema	At 48 hours after surgery
Primary	subcutaneous emphysema 3	incidence of subcutaneous emphysema	At 72 hours after surgery
Secondary	Tube obstruction	tube obstructed by blood clots	during chest tube removal procedure
Secondary	Pain related to chest tube 1	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)	At 24 hours after surgery
Secondary	Pain related to chest tube 2	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)	At 48 hours after surgery
Secondary	Pain related to chest tube 3	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)	At 72 hours after surgery
Secondary	Pain related to chest tube 4	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)	At 96 hours after surgery