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OpenTrials
Completed

NCT Number: NCT01747889

Objective and Subjective Outcomes of an Electronic Chest Drainage System

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.

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Key information

Conditions

Lung Cancer Behavior Health Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Patient Satisfaction Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedali Riuniti Ancona

Ancona, 60122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Duration of chest tubes

    Time frame: date of chest tube removal

Secondary outcomes

  1. total distance of ambulation in the first 48 postoperative hours

    Time frame: 48 hours after surgery

Other outcomes

  1. overall patient satisfaction with chest drainage system.

    Time frame: 48 hours after surgery

Sponsors and collaborators

Lead sponsor

Ospedali Riuniti Ancona

Other

Collaborators

  • The Leeds Teaching Hospitals NHS Trust
  • The University of Hong Kong
  • Yale University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Mar 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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