Comparison Between Electronic and Traditional Chest Drainage Systems

October 1, 2019 updated by: PROF. GIUSEPPE MARULLI, University Hospital Padova

Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Lecce, Italy
        • Recruiting
        • Thoracic Surgery Unit, Vito Fazzi Hospital
        • Contact:
          • Gaetano Di Rienzo
        • Contact:
          • Camillo Lopez
      • Milano, Italy
      • Napoli, Italy
        • Not yet recruiting
        • Thoracic Surgery Unit, Monaldi Hospital
        • Contact:
          • Carlo Curcio
        • Contact:
          • Rosario Salvi
      • Padova, Italy, 35128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of chest drainage
Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days
from date of surgery to date of chest tube removal, assessed up to 8 days
Post-operative hospital length of stay
Time Frame: from date of surgery to date of hospital discharge, assessed up to 8 days
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
Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days
from date of surgery to date of chest tube removal, assessed up to 8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days
from date of surgery to date of chest tube removal, assessed up to 8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Monaldi Hospital
Vito Fazzi Hospital

Investigators

  • Principal Investigator: Giuseppe Marulli, MD, PhD, Thoracic Surgery Unit - University Hospital of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2017

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

April 20, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4013/AO/16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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