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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion; Chest Tubes; Video Assisted Thoracic Surgery
• Intervention / Treatment: Procedure: 28Fr "coaxial smart drain" chest tube

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.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery	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.
No Intervention: Study group 1; All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery
Experimental: Study group 2; All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid output 1	Total fluid amount	At 24 hours from surgery
Fluid output 2	Total fluid amount	At 48 hours from surgery
Fluid output 3	Total fluid amount	At 72 hours from surgery
Fluid output 4	Total fluid amount	At 96 hours from surgery
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
subcutaneous emphysema 1	incidence of subcutaneous emphysema	At 24 hours after surgery
subcutaneous emphysema 2	incidence of subcutaneous emphysema	At 48 hours after surgery
subcutaneous emphysema 3	incidence of subcutaneous emphysema	At 72 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tube obstruction	tube obstructed by blood clots	during chest tube removal procedure
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
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
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
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Dania Nachira, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: ID 2388

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No