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

Primary Purpose

Pleural Effusion, Video Assisted Thoracic Surgery, Chest Tubes

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
28Fr "coaxial smart drain" chest tube
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pleural Effusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Study group

Study group 1

Study group 2

Arm Description

All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery

All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery

Outcomes

Primary Outcome Measures

Fluid output 1
Total fluid amount
Fluid output 2
Total fluid amount
Fluid output 3
Total fluid amount
Fluid output 4
Total fluid amount
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
subcutaneous emphysema 1
incidence of subcutaneous emphysema
subcutaneous emphysema 2
incidence of subcutaneous emphysema
subcutaneous emphysema 3
incidence of subcutaneous emphysema

Secondary Outcome Measures

Tube obstruction
tube obstructed by blood clots
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)
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)
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)
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)

Full Information

First Posted
February 21, 2023
Last Updated
September 12, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT06036667
Brief Title
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
Official Title
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Video Assisted Thoracic Surgery, Chest Tubes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
177 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
Arm Title
Study group 1
Arm Type
No Intervention
Arm Description
All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery
Arm Title
Study group 2
Arm Type
Experimental
Arm Description
All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery
Intervention Type
Procedure
Intervention Name(s)
28Fr "coaxial smart drain" chest tube
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fluid output 1
Description
Total fluid amount
Time Frame
At 24 hours from surgery
Title
Fluid output 2
Description
Total fluid amount
Time Frame
At 48 hours from surgery
Title
Fluid output 3
Description
Total fluid amount
Time Frame
At 72 hours from surgery
Title
Fluid output 4
Description
Total fluid amount
Time Frame
At 96 hours from surgery
Title
Residual pleural effusion at chest X-Ray
Description
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
Time Frame
72 hours after surgery
Title
subcutaneous emphysema 1
Description
incidence of subcutaneous emphysema
Time Frame
At 24 hours after surgery
Title
subcutaneous emphysema 2
Description
incidence of subcutaneous emphysema
Time Frame
At 48 hours after surgery
Title
subcutaneous emphysema 3
Description
incidence of subcutaneous emphysema
Time Frame
At 72 hours after surgery
Secondary Outcome Measure Information:
Title
Tube obstruction
Description
tube obstructed by blood clots
Time Frame
during chest tube removal procedure
Title
Pain related to chest tube 1
Description
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)
Time Frame
At 24 hours after surgery
Title
Pain related to chest tube 2
Description
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)
Time Frame
At 48 hours after surgery
Title
Pain related to chest tube 3
Description
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)
Time Frame
At 72 hours after surgery
Title
Pain related to chest tube 4
Description
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)
Time Frame
At 96 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dania Nachira, MD
Phone
3295882588
Email
dania.nachira@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dania Nachira, MD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dania Nachira, MD
Email
dania.nachira@policlinicogemelli.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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