Objective and Subjective Outcomes of an Electronic Chest Drainage System

NCT01747889 | Completed

• 1 other identifier: PATSAT-2012-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

chest tube; lung resection; patient satisfaction; mobility

Outcome Measures

Primary Outcomes (1)

• Duration of chest tubes

  date of chest tube removal

Secondary Outcomes (1)

• total distance of ambulation in the first 48 postoperative hours

  48 hours after surgery

Other Outcomes (1)

• overall patient satisfaction with chest drainage system.

  48 hours after surgery

Study Arms (2)

Electronic system

EXPERIMENTAL

patients managed with an electronic chest drainage system

Device: electronic chest drainage system

traditional system

NO INTERVENTION

patients managed with a traditional analogue chest drainage system

Interventions

electronic chest drainage system DEVICE

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

Electronic system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients unstable enough to require ICU care upon completion of the resection
• Redo thoracotomies

Sponsors & Collaborators

• Ospedali Riuniti Ancona: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator
• The University of Hong Kong: collaborator
• Yale University: collaborator

Study Sites (1)

Ospedali Riuniti Ancona

Ancona, 60122, Italy

Location

Related Publications (1)

• 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.

  PMID: 24906602 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Cecilia Pompili, MD

  Ospedali Riuniti Ancona, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 12, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

IT (1)