Objective and Subjective Outcomes of an Electronic Chest Drainage System

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747889
• Other study ID #: PATSAT-2012-1
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: March 28, 2016
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Ospedali Riuniti Ancona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedali Riuniti Ancona	Ancona

Sponsors (4)

Lead Sponsor	Collaborator
Ospedali Riuniti Ancona	The Leeds Teaching Hospitals NHS Trust, The University of Hong Kong, Yale University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall patient satisfaction with chest drainage system.		48 hours after surgery	No
Primary	Duration of chest tubes		date of chest tube removal	No
Secondary	total distance of ambulation in the first 48 postoperative hours		48 hours after surgery	No