Objective and Subjective Outcomes of an Electronic Chest Drainage System

Ospedali Riuniti Ancona

Status: Completed

Conditions: Lung Cancer

Treatments: Device: electronic chest drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT01747889

PATSAT-2012-1

Details and patient eligibility

About

This study is designed to compare the Thopaz chest tube drainage system to the traditional collection chamber system. The Thopaz system is already in clinical use in the United States and throughout the world. As such, this study is not evaluating safety or efficacy of this system both of which have already been demonstrated. This study's primary aim is to determine whether the use of a digital chest drainage system compared with a traditional system affects duration of chest drainage and length of hospital stay.

Furthermore, we aim to determine whether the use of a digital chest drainage system compared with a traditional system increases the total distance of ambulation in the first 48 hours after thoracic surgery and affects overall patient satisfaction in the peri-operative period.

Finally, we want to determine whether the aforementioned outcomes relative to the chest tube drainage systems differ in different parts of the world.

Enrollment: 400 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to read, understand, and provide written Informed Consent
2. Age range of 18-90 years
3. Patients undergoing a segmentectomy, lobectomy, or bilobectomy. Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable.

Exclusion criteria

1. Patients unstable enough to require ICU care upon completion of the resection
2. Redo thoracotomies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Electronic system

Experimental group

Description:

patients managed with an electronic chest drainage system

Treatment:

Device: electronic chest drainage system

traditional system

No Intervention group

Description:

patients managed with a traditional analogue chest drainage system