Comparison Between Electronic and Traditional Chest Drainage Systems

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: Electronic chest drainage system

• Registration Number: NCT03536130
• Lead Sponsor: University Hospital Padova

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 available

Study Timeline

• Study Start: 2017-04-04
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-02
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 382

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic chest drainage system	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.

Primary Outcome Measures

Name	Time	Method
Duration of chest drainage	from date of surgery to date of chest tube removal, 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
Post-operative hospital length of stay	from date of surgery to date of hospital discharge, assessed up to 8 days

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (4)

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, Italy