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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

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2018)
  • Duration of chest drainage [ Time Frame: 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Duration of chest drainage [ Time Frame: 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 ]
  • Quantification of 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. [ Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2018)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • 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 ]
  • Identification of potential predictors of prolonged air leaks. [ Time Frame: from date of surgery to date of chest tube removal, assessed up to 8 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Electronic and Traditional Chest Drainage Systems
Official Title  ICMJE Multicenter Randomized Study on Comparison Between Electronic and Traditional Chest Drainage Systems
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Electronic chest drainage system
  • 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2018)
382
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Giuseppe Marulli, MD, PhD +39-0498212242 giuseppe.marulli@unipd.it
Contact: Giovanni Comacchio, MD +39-0498212242 giovannimaria.comacchio@aopd.veneto.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536130
Other Study ID Numbers  ICMJE 4013/AO/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PROF. GIUSEPPE MARULLI, University Hospital Padova
Study Sponsor  ICMJE University Hospital Padova
Collaborators  ICMJE
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Vito Fazzi Hospital
  • Monaldi Hospital
Investigators  ICMJE
Principal Investigator: Giuseppe Marulli, MD, PhD Thoracic Surgery Unit - University Hospital of Padova
PRS Account University Hospital Padova
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP