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Objective and Subjective Outcomes of an Electronic Chest Drainage System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01747889
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : March 29, 2016
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

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.


Condition or disease Intervention/treatment
Lung Cancer Device: electronic chest drainage system

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Objective and Subjective Outcomes of an Electronic Chest Drainage System Versus Traditional Devices: a Randomized Comparison
Study Start Date : January 2013
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Duration of chest tubes [ Time Frame: date of chest tube removal ]

Secondary Outcome Measures :
  1. total distance of ambulation in the first 48 postoperative hours [ Time Frame: 48 hours after surgery ]

Other Outcome Measures:
  1. overall patient satisfaction with chest drainage system. [ Time Frame: 48 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747889


Locations
Italy
Ospedali Riuniti Ancona
Ancona, Italy, 60122
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cecilia Pompili, MD, Ospedali Riuniti Ancona
ClinicalTrials.gov Identifier: NCT01747889     History of Changes
Other Study ID Numbers: PATSAT-2012-1
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: March 29, 2016
Last Verified: March 2016

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