Objective and Subjective Outcomes of an Electronic Chest Drainage System

Study Overview
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Brief Summary
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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.

Official Title
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Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: electronic chest drainage system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to read, understand, and provide written Informed Consent Age range of 18-90 years Patients undergoing a segmentectomy, lobectomy, or bilobectomy. Both open and minimally invasive (thoracoscopic or robotic) resections are acceptable. Exclusion Criteria: Patients unstable enough to require ICU care upon completion of the resection Redo thoracotomies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic system<br>patients managed with an electronic chest drainage system | Device: electronic chest drainage system<br>* Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1. On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients<br>|
| No Intervention: traditional system<br>patients managed with a traditional analogue chest drainage system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of chest tubes |  | date of chest tube removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total distance of ambulation in the first 48 postoperative hours |  | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest tube, lung resection, patient satisfaction, mobility