Pleural EffusionNCT06036667
Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
A study testing 28Fr "coaxial smart drain" chest tube in people with Pleural Effusion and Video Assisted Thoracic Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pleural Effusion, Video Assisted Thoracic Surgery, Chest Tubes
- What is being tested?
- 28Fr "coaxial smart drain" chest tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteItaly
- Study dates
- 5 Mar 2019to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS
Who cannot join
- Patients undergone open surgery
- Patients undergone middle or lower lobectomies
- Patients undergone chest wall/or wedge resections
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
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.
Read the 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.
- Being tested
- 28Fr "coaxial smart drain" chest tube
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
28Fr "coaxial smart drain" chest tubeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery Receives: Procedure: 28Fr "coaxial smart drain" chest tube |
| Study group 1 | No intervention | All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery |
| Study group 2 | Experimental | All patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery Receives: Procedure: 28Fr "coaxial smart drain" chest tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid output 1
Total fluid amount
Measured: At 24 hours from surgery
Fluid output 2
Total fluid amount
Measured: At 48 hours from surgery
Fluid output 3
Total fluid amount
Measured: At 72 hours from surgery
Fluid output 4
Total fluid amount
Measured: 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
Measured: 72 hours after surgery
subcutaneous emphysema 1
incidence of subcutaneous emphysema
Measured: At 24 hours after surgery
subcutaneous emphysema 2
incidence of subcutaneous emphysema
Measured: At 48 hours after surgery
subcutaneous emphysema 3
incidence of subcutaneous emphysema
Measured: At 72 hours after surgery
Secondary outcomes (5)
Tube obstruction
tube obstructed by blood clots
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At 96 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start5 Mar 2019
- Primary completion30 Jul 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dania Nachira, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036667
- Sponsor's protocol ID
- ID 2388
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Coaxial Smart Drain (Redax TM) in Uniportal-VATS
- ClinicalTrials.gov ID
- NCT06036667
- Acronym / sponsor ID
- ID 2388
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: 28Fr "coaxial smart drain" chest tubeAll patients undergone Uniportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery |
| Study group 1 | No intervention | –All patients undergone Uniportal-VATS upper lobectomy with standard 28Fr chest drain placed at the end of surgery |
| Study group 2 | Experimental | Procedure: 28Fr "coaxial smart drain" chest tubeAll patients undergone Biportal-VATS upper lobectomy with 28Fr Smart Coaxial drain placed at the end of surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergone upper right or left lobectomy in Uniportal- or Biportal-VATS
Key exclusion criteria (3 listed)
- Patients undergone open surgery
- Patients undergone middle or lower lobectomies
- Patients undergone chest wall/or wedge resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 28Fr "coaxial smart drain" chest tubeTo 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. | Procedure or surgery | Study group, Study group 2 |
Primary outcome
Fluid output 1
Time frame: At 24 hours from surgery
Total fluid amount
Fluid output 2
Time frame: At 48 hours from surgery
Total fluid amount
Fluid output 3
Time frame: At 72 hours from surgery
Total fluid amount
Fluid output 4
Time frame: At 96 hours from surgery
Total fluid amount
Residual pleural effusion at chest X-Ray
Time frame: 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
Time frame: At 24 hours after surgery
incidence of subcutaneous emphysema
subcutaneous emphysema 2
Time frame: At 48 hours after surgery
incidence of subcutaneous emphysema
subcutaneous emphysema 3
Time frame: At 72 hours after surgery
incidence of subcutaneous emphysema
5 secondary outcomes
Tube obstruction
Time frame: during chest tube removal procedure
Pain related to chest tube 1
Time frame: At 24 hours after surgery
Pain related to chest tube 2
Time frame: At 48 hours after surgery
Pain related to chest tube 3
Time frame: At 72 hours after surgery
Pain related to chest tube 4
Time frame: At 96 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dania Nachira, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 28Fr "coaxial smart drain" chest tube in people with Pleural Effusion and Video Assisted Thoracic Surgery, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid output 1 (time frame: At 24 hours from surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.