Comparison Between Electronic and Traditional Chest Drainage Systems
Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
1 other identifier
interventional
382
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable lung-cancer
Started Apr 2017
Typical duration for not_applicable lung-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedOctober 2, 2019
October 1, 2019
3 years
April 20, 2018
October 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (2)
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
from date of surgery to date of chest tube removal, assessed up to 8 days
Study Arms (2)
Electronic chest drainage system
EXPERIMENTALPatients 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 INTERVENTIONPatients 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.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Padovalead
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicocollaborator
- Vito Fazzi Hospitalcollaborator
- Monaldi Hospitalcollaborator
Study Sites (4)
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, 35128, Italy
Related Publications (2)
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.
PMID: 34225743DERIVEDMarulli 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.
PMID: 31842974DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Marulli, MD, PhD
Thoracic Surgery Unit - University Hospital of Padova
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 24, 2018
Study Start
April 4, 2017
Primary Completion
March 31, 2020
Study Completion
March 31, 2020
Last Updated
October 2, 2019
Record last verified: 2019-10