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Comparison Between Electronic and Traditional Chest Drainage Systems

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ClinicalTrials.gov Identifier: NCT03536130
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Vito Fazzi Hospital
Monaldi Hospital
Information provided by (Responsible Party):
PROF. GIUSEPPE MARULLI, University Hospital Padova

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Device: Electronic chest drainage system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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

No Intervention: 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.



Primary Outcome Measures :
  1. Duration of chest drainage [ Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days ]
  2. Post-operative hospital length of stay [ Time Frame: from date of surgery to date of hospital discharge, assessed up to 8 days ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536130


Contacts
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Contact: Giuseppe Marulli, MD, PhD +39-0498212242 giuseppe.marulli@unipd.it
Contact: Giovanni Comacchio, MD +39-0498212242 giovannimaria.comacchio@aopd.veneto.it

Locations
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Italy
Thoracic Surgery Unit, Vito Fazzi Hospital Recruiting
Lecce, Italy
Contact: Gaetano Di Rienzo         
Contact: Camillo Lopez         
Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy Recruiting
Milano, Italy
Contact: Mario Nosotti       mario.nosotti@policlinico.mi.it   
Contact: Paolo Mendogni       paolo.mendogni@policlinico.mi.it   
Thoracic Surgery Unit, Monaldi Hospital Not yet recruiting
Napoli, Italy
Contact: Carlo Curcio         
Contact: Rosario Salvi         
Thoracic Surgery Unit - University of Padova Recruiting
Padova, Italy, 35128
Contact: Federico Rea, MD    +39-0498212237    chirurgia.toracica@aopd.veneto.it   
Contact: Giuseppe Marulli, MD, PhD    +39-0498212242    chirurgia.toracica@aopd.veneto.it   
Sponsors and Collaborators
University Hospital Padova
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Vito Fazzi Hospital
Monaldi Hospital
Investigators
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Principal Investigator: Giuseppe Marulli, MD, PhD Thoracic Surgery Unit - University Hospital of Padova
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: PROF. GIUSEPPE MARULLI, MD, PhD, University Hospital Padova
ClinicalTrials.gov Identifier: NCT03536130    
Other Study ID Numbers: 4013/AO/16
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PROF. GIUSEPPE MARULLI, University Hospital Padova:
chest tube, lung resection, air leakage