Objective and Subjective Outcomes of an Electronic Chest Drainage System

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

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 Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: electronic chest drainage system

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60122
    • Ospedali Riuniti Ancona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electronic system; patients managed with an electronic chest drainage system	Device: electronic chest drainage system; 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
NO_INTERVENTION: traditional system; patients managed with a traditional analogue chest drainage system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of chest tubes	date of chest tube removal

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
overall patient satisfaction with chest drainage system.	48 hours after surgery

Collaborators and Investigators

• Sponsor: Ospedali Riuniti Ancona
• Collaborators: The University of Hong Kong; Yale University; The Leeds Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Cecilia Pompili, MD, Ospedali Riuniti Ancona, Italy

Publications and helpful links

General Publications

• Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (ESTIMATE): December 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 29, 2016
• Last Update Submitted That Met QC Criteria: March 28, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: mobility; lung resection; patient satisfaction; chest tube
• Other Study ID Numbers: PATSAT-2012-1