Comparison Between Electronic and Traditional Chest Drainage Systems
NCT ID: NCT03536130
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
382 participants
INTERVENTIONAL
2017-04-04
2020-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Electronic chest drainage system
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.
Electronic chest drainage system
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
Traditional device
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.
No interventions assigned to this group
Interventions
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Electronic chest drainage system
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Vito Fazzi Hospital
UNKNOWN
Monaldi Hospital
OTHER
University Hospital Padova
OTHER
Responsible Party
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PROF. GIUSEPPE MARULLI
MD, PhD
Principal Investigators
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Giuseppe Marulli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Thoracic Surgery Unit - University Hospital of Padova
Locations
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Thoracic Surgery Unit, Vito Fazzi Hospital
Lecce, , Italy
Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy
Milan, , Italy
Thoracic Surgery Unit, Monaldi Hospital
Napoli, , Italy
Thoracic Surgery Unit - University of Padova
Padua, , Italy
Countries
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Central Contacts
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Facility Contacts
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Gaetano Di Rienzo
Role: primary
Camillo Lopez
Role: backup
Carlo Curcio
Role: primary
Rosario Salvi
Role: backup
References
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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.
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.
Other Identifiers
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4013/AO/16
Identifier Type: -
Identifier Source: org_study_id
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