Comparison Between Electronic and Traditional Chest Drainage Systems

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536130
• Other study ID #: 4013/AO/16
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2019
• Source: University Hospital Padova
• Contact: Giuseppe Marulli, MD, PhD
• Phone: +39-0498212242
• Email: giuseppe.marulli[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 382
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	Thoracic Surgery Unit, Vito Fazzi Hospital	Lecce
Italy	Thoracic Surgery Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy	Milano
Italy	Thoracic Surgery Unit, Monaldi Hospital	Napoli
Italy	Thoracic Surgery Unit - University of Padova	Padova

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Padova	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Monaldi Hospital, Vito Fazzi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of chest drainage		from date of surgery to date of chest tube removal, assessed up to 8 days
Primary	Post-operative hospital length of stay		from date of surgery to date of hospital discharge, assessed up to 8 days
Primary	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	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
Secondary	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