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| Name | Class |
|---|---|
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
| Vito Fazzi Hospital | UNKNOWN |
| Monaldi Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic chest drainage system | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of chest drainage | from date of surgery to date of chest tube removal, assessed up to 8 days | |
| Post-operative hospital length of stay | 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 | from date of surgery to date of chest tube removal, assessed up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Marulli, MD, PhD | Contact | +39-0498212242 | giuseppe.marulli@unipd.it | |
| Giovanni Comacchio, MD | Contact | +39-0498212242 | giovannimaria.comacchio@aopd.veneto.it |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Marulli, MD, PhD | Thoracic Surgery Unit - University Hospital of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Unit, Vito Fazzi Hospital | Recruiting | Lecce | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34225743 | Derived | 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. | |
| 31842974 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Allocation: randomization 1 to 1 Endpoint classification: efficacy study Masking: Open label Intervention model: parallel assignment Primary purpose: supportive care
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| from date of surgery to date of chest tube removal, assessed up to 8 days |
| Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy | Recruiting | Milan | Italy |
|
| Thoracic Surgery Unit, Monaldi Hospital | Not yet recruiting | Naples | Italy |
|
| Thoracic Surgery Unit - University of Padova | Recruiting | Padova | 35128 | Italy |
|
| Marulli 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |