Comparison Between Electronic and Traditional Chest Drainage Systems

University Hospital Padova

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: Electronic chest drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT03536130

4013/AO/16

Details and patient eligibility

About

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.

Enrollment: 382 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

Electronic chest drainage system

Experimental group

Description:

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.

Treatment:

Device: Electronic chest drainage system

Traditional device

No Intervention group

Description:

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.