Objective and Subjective Outcomes of an Electronic Chest Drainage System

Ospedali Riuniti Ancona400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

400

Conditions

Lung Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Duration of chest tubes

Time frame: date of chest tube removal

Secondary Outcomes

total distance of ambulation in the first 48 postoperative hours

Time frame: 48 hours after surgery