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Objective and Subjective Outcomes of an Electronic Chest Drainage System

This study is not yet open for participant recruitment.
Verified December 2012 by Ospedali Riuniti Ancona
Sponsor:
Collaborators:
The Leeds Teaching Hospitals NHS Trust
The University of Hong Kong
Yale University
Information provided by (Responsible Party):
Cecilia Pompili, Ospedali Riuniti Ancona
ClinicalTrials.gov Identifier:
NCT01747889
First received: December 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Lung Cancer
 Device: electronic chest drainage system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Ospedali Riuniti Ancona:

Primary Outcome Measures:
  • Duration of chest tubes [ Time Frame: date of chest tube removal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total distance of ambulation in the first 48 postoperative hours [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • overall patient satisfaction with chest drainage system. [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01747889

Contacts
Contact: Cecilia Pompili, MD +390715964439 ceciliapompili@gmail.com

Locations
Italy
Ospedali Riuniti Ancona Not yet recruiting
Ancona, Italy, 60122
Contact: Cecilia Pompili, MD     +390715964439     ceciliapompili@gmail.com    
Principal Investigator: Cecilia Pompili, MD            
Sponsors and Collaborators
Ospedali Riuniti Ancona
The Leeds Teaching Hospitals NHS Trust
The University of Hong Kong
Yale University
Investigators
Principal Investigator: Cecilia Pompili, MD Ospedali Riuniti Ancona, Italy
  More Information

No publications provided

Responsible Party: Cecilia Pompili, MD, Ospedali Riuniti Ancona
ClinicalTrials.gov Identifier: NCT01747889     History of Changes
Other Study ID Numbers: PATSAT-2012-1
Study First Received: December 7, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ospedali Riuniti Ancona:
chest tube
lung resection
patient satisfaction
mobility

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013