Objective and Subjective Outcomes of an Electronic Chest Drainage System

Not Applicable

Completed

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

• Registration Number: NCT01747889
• Lead Sponsor: Ospedali Riuniti Ancona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic system	electronic chest drainage system	patients managed with an electronic chest drainage system

Primary Outcome Measures

Name	Time	Method
Duration of chest tubes	date of chest tube removal

Secondary Outcome Measures

Name	Time	Method
total distance of ambulation in the first 48 postoperative hours	48 hours after surgery

Trial Locations

Locations (1)

Ospedali Riuniti Ancona; 🇮🇹 Ancona, Italy