Clinical trial NCT03536130: Comparison Between Electronic and Traditional Chest Drainage Systems
Official title: Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: chest tube, lung resection, air leakage
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Vito Fazzi Hospital
name: Monaldi Hospital
First posted: 2018-05-24
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: randomization 1 to 1 Endpoint classification: efficacy study Masking: Open label Intervention model: parallel assignment Primary purpose: supportive care
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Duration of chest drainage
timeFrame: from date of surgery to date of chest tube removal, assessed up to 8 days
measure: Post-operative hospital length of stay
timeFrame: from date of surgery to date of hospital discharge, assessed up to 8 days
measure: 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
timeFrame: from date of surgery to date of chest tube removal, assessed up to 8 days
Secondary outcomes:
measure: Evaluation of intrapleural differential pressure in case of active air leak and in case of pleural space effect
timeFrame: from date of surgery to date of chest tube removal, assessed up to 8 days
measure: Identification of potential predictors of prolonged air leaks through the analysis of the data registered by the digital system
timeFrame: from date of surgery to date of chest tube removal, assessed up to 8 days
Other outcomes:
Locations:
city: Lecce
country: Italy
facility: Thoracic Surgery Unit, Vito Fazzi Hospital
city: Milano
country: Italy
facility: Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy
city: Napoli
country: Italy
facility: Thoracic Surgery Unit, Monaldi Hospital
city: Padova
country: Italy
facility: Thoracic Surgery Unit - University of Padova
Study officials:
affiliation: Thoracic Surgery Unit - University Hospital of Padova
name: Giuseppe Marulli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.