Lung CancerNCT03536130
Comparison Between Electronic and Traditional Chest Drainage Systems
A study testing Electronic chest drainage system in people with Lung Cancer, run by University Hospital Padova at 4 sites in Italy.
Trial summary
This study is designed to compare the electronic chest drainage system (Drentech Palm Evo) with the traditional system, both already in use in the clinical practice, in a cohort of patients who received thoracoscopic lobectomy. This study is not evaluating safety or efficacy of these systems. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Electronic chest drainage system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 4 sitesItaly
- Study dates
- 4 Apr 2017to 31 Mar 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to read, understand and provide written informed consent
- Patients undergoing thoracoscopic lobectomy
- Age 18 - 80 years
- Gender: both
- Estimated life expectancy of at least 6 months.
- Tumour considered potentially resectable by R0 surgery
- Adequate respiratory function for surgery.
- Must have signed and dated an informed consent form (ICF), before performance of any study-specific procedures or tests. Subjects must be fully informed about their illness and the investigational nature of the study protocol.
Who cannot join
- Patients requiring ICU care with mechanical ventilation
- Patients needing reintervention during postoperative care
- Patients requiring a thoracotomy
- Tumour considered potentially resectable by incomplete surgical resection with microscopic residual disease (R1) or gross residual disease (R2).
- Evidence of extra-thoracic disease.
- Major thoracic surgical procedure before enrolment.
- Any other significant co-morbid condition that, in opinion of the investigator, would impair study participation or cooperation.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Thoracic Surgery Unit, Vito Fazzi Hospital
Lecce
Gaetano Di Rienzo
Camillo Lopez
- Recruiting
Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy
Milan
Mario Nosotti, mario.nosotti@policlinico.mi.it
Paolo Mendogni, paolo.mendogni@policlinico.mi.it
- Not yet recruiting
Thoracic Surgery Unit, Monaldi Hospital
Naples
Carlo Curcio
Rosario Salvi
- Recruiting
Thoracic Surgery Unit - University of Padova
Padova, 35128
Federico Rea, MD, +39-0498212237, chirurgia.toracica@aopd.veneto.it
Giuseppe Marulli, MD, PhD, +39-0498212242, chirurgia.toracica@aopd.veneto.it
About this study
Official title: Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
This study is designed to compare the electronic chest drainage system (Drentech Palm Evo) with the traditional system, both already in use in the clinical practice, in a cohort of patients who received thoracoscopic lobectomy. This study is not evaluating safety or efficacy of these systems.
This study's primary aim is to determine if the use of a digital chest system compared with a traditional system reduce the duration of chest drainage and length of hospital stay. Moreover, the investigators aim to quantify the variability of results regarding the subjective observer evaluation of active air leaks (through the traditional system) compared with the objective data registered by the digital system.
Finally the investigators want to evaluate whether it is possible through the digital device to distinguish an active air leak from a pleural space effect by the evaluation of intrapleural differential pressure and to identify potential predictors of prolonged air leaks.
- Conditions
- Lung Cancer
- Being tested
- Electronic chest drainage system
- Keywords
- chest tube, lung resection, air leakage
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic chest drainage systemDevice
Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. Management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms and surgeon preference following standard clinical practice of general thoracic patients
| Study group | Role | What they receive |
|---|---|---|
| Electronic chest drainage system | Experimental | Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. Receives: Device: Electronic chest drainage system |
| Traditional device | No intervention | Patients in the no intervention (traditional) arm are connected to traditional drain system with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with traditional devices (requiring connection to wall suction) are managed by applying suction (-20 cmH2O) until the morning of POD 1 and are subsequently disconnected from suction thereafter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of chest drainage
Measured: from date of surgery to date of chest tube removal, assessed up to 8 days
Post-operative hospital length of stay
Measured: from date of surgery to date of hospital discharge, assessed up to 8 days
Evaluation of the degree of concordance between the subjective observer evaluation of active air leaks compared with the objective data registered by the digital system in the patients with electronic chest drainage system
Measured: from date of surgery to date of chest tube removal, assessed up to 8 days
Secondary outcomes (2)
Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect
Measured: from date of surgery to date of chest tube removal, assessed up to 8 days
Identification of potential predictors of prolonged air leaks through the analysis of the data registered by the digital system
Measured: from date of surgery to date of chest tube removal, assessed up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start4 Apr 2017
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: randomization 1 to 1 Endpoint classification: efficacy study Masking: Open label Intervention model: parallel assignment Primary purpose: supportive care
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Vito Fazzi Hospital, Monaldi Hospital
- Responsible party
- Principal investigator, PROF. GIUSEPPE MARULLI, University Hospital Padova
- Investigators
- Giuseppe Marulli, MD, PhD, Principal investigator, Thoracic Surgery Unit - University Hospital of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536130
- Sponsor's protocol ID
- 4013/AO/16
- Status last verified
- Oct 2019
- First submitted
- 20 Apr 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mendogni P, Tosi D, Marulli G, Comacchio GM, Pieropan S, Rossi V, Brascia D, Andriolo LG, Imbriglio G, Bonitta G, Lopez C, Rea F, Nosotti M. Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis. J Cardiothorac Surg. 2021 Jul 5;16(1):188. doi: 10.1186/s13019-021-01567-y.
PubMed 34225743Marulli G, Comacchio GM, Nosotti M, Rosso L, Mendogni P, Natale G, Andriolo L, Imbriglio G, Larocca V, Brascia D, Rea F. Multicenter randomized study on the comparison between electronic and traditional chest drainage systems. Trials. 2019 Dec 16;20(1):730. doi: 10.1186/s13063-019-3811-8.
PubMed 31842974
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
- ClinicalTrials.gov ID
- NCT03536130
- Acronym / sponsor ID
- 4013/AO/16
- Conditions
- Lung Cancer
- Keywords
- chest tube, lung resection, air leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Vito Fazzi Hospital, Monaldi Hospital
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 24 May 2018 (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.
This study is designed to compare the electronic chest drainage system (Drentech Palm Evo) with the traditional system, both already in use in the clinical practice, in a cohort of patients who received thoracoscopic lobectomy. This study is not evaluating safety or efficacy of these systems.
This study's primary aim is to determine if the use of a digital chest system compared with a traditional system reduce the duration of chest drainage and length of hospital stay. Moreover, the investigators aim to quantify the variability of results regarding the subjective observer evaluation of active air leaks (through the traditional system) compared with the objective data registered by the digital system.
Finally the investigators want to evaluate whether it is possible through the digital device to distinguish an active air leak from a pleural space effect by the evaluation of intrapleural differential pressure and to identify potential predictors of prolonged air leaks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation: randomization 1 to 1 Endpoint classification: efficacy study Masking: Open label Intervention model: parallel assignment Primary purpose: supportive care
| Arm | Type | Receives |
|---|---|---|
| Electronic chest drainage system | Experimental | Device: Electronic chest drainage systemPatients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. |
| Traditional device | No intervention | –Patients in the no intervention (traditional) arm are connected to traditional drain system with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with traditional devices (requiring connection to wall suction) are managed by applying suction (-20 cmH2O) until the morning of POD 1 and are subsequently disconnected from suction thereafter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able and willing to read, understand and provide written informed consent
- Patients undergoing thoracoscopic lobectomy
- Age 18 - 80 years
- Gender: both
- Estimated life expectancy of at least 6 months.
Key exclusion criteria (7 listed)
- Patients requiring ICU care with mechanical ventilation
- Patients needing reintervention during postoperative care
- Patients requiring a thoracotomy
- Tumour considered potentially resectable by incomplete surgical resection with microscopic residual disease (R1) or gross residual disease (R2).
- Evidence of extra-thoracic disease.
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 |
|---|---|---|
| Electronic chest drainage systemPatients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. Management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms and surgeon preference following standard clinical practice of general thoracic patients | Device | Electronic chest drainage system |
Primary outcome
Duration of chest drainage
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Post-operative hospital length of stay
Time frame: from date of surgery to date of hospital discharge, assessed up to 8 days
Evaluation of the degree of concordance between the subjective observer evaluation of active air leaks compared with the objective data registered by the digital system in the patients with electronic chest drainage system
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
2 secondary outcomes
Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Identification of potential predictors of prolonged air leaks through the analysis of the data registered by the digital system
Time frame: from date of surgery to date of chest tube removal, assessed up to 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Derived from this study: PubMed 34225743Mendogni P, Tosi D, Marulli G, Comacchio GM, Pieropan S, Rossi V, Brascia D, Andriolo LG, Imbriglio G, Bonitta G, Lopez C, Rea F, Nosotti M. Multicenter randomized controlled trial comparing digital and traditional chest drain in a VATS pulmonary lobectomy cohort: interim analysis. J Cardiothorac Surg. 2021 Jul 5;16(1):188. doi: 10.1186/s13019-021-01567-y.
- Derived from this study: PubMed 31842974Marulli G, Comacchio GM, Nosotti M, Rosso L, Mendogni P, Natale G, Andriolo L, Imbriglio G, Larocca V, Brascia D, Rea F. Multicenter randomized study on the comparison between electronic and traditional chest drainage systems. Trials. 2019 Dec 16;20(1):730. doi: 10.1186/s13063-019-3811-8.
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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.
Giuseppe Marulli, MD, PhD principal investigator
Thoracic Surgery Unit - University Hospital of Padova
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic chest drainage system in people with Lung Cancer, run by University Hospital Padova at 4 sites 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Marulli, MD, PhD (+39-0498212242, giuseppe.marulli@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of chest drainage (time frame: from date of surgery to date of chest tube removal, assessed up to 8 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536130, which also lists 2 linked publications.
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 2 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.