Experiences With New Digital Surgical Drainage System in Thoracic Surgery

Pulmonary Air Leak Clinical Trial

Official title:

Experiences With New Digital Surgical Drainage System in Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068545
• Other study ID #: CRD-1675
• Status: Completed
• Start date: September 2, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: Centese, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the Thoraguard Surgical Drainage System in a real-world clinical environment. It is believed that this system will offer functional and clinical benefits over the current standard of care system for the removal of surgical fluids and air following thoracic surgery. Observations, experiences, and outcomes in a single hospital setting will be collected for the Thoraguard Surgical Drainage System.

Description:

The Thoraguard System is intended for use for drainage of blood, fluids, and gases following cardiac and thoracic surgery. The system consists of an electronic control module and drainage kit (fluid collection canister and drainage line) which connect to a proprietary chest tube but may also connect to other thoracic drainage catheters. The system continuously monitors line patency, automatically clears the chest tube (when used with Thoraguard Chest Tube) and drainage line from build-up, and provides digital readings of fluid output trends. The system is battery powered with integrated suction for ease of ambulation.

Additionally, the system has patient safety alarms to notify clinical staff of unexpected events associated with postoperative drainage. These functions offer significant improvements over the current standard of care. Reliable post-operative drainage, reduced workload, and decreased variability in chest tube maintenance procedures have the potential to increase patient safety, reduce complications, and improve the patient experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (age = 18)

• Patient undergoing non-emergent thoracic surgery (Sternotomy, Video-Assisted Thoracoscopic Surgery (VATS), Thoracotomy, or Robotic)

• Expected requirement for chest drain monitoring of air leak for at least 24h post-operation

• A requirement for a surgical drainage system

Exclusion Criteria:

• Emergency surgery

• Re-do surgery

• Prior thoracic surgery

• Transplant Surgery

• In the opinion of the investigator, the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications

• Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial

• Pregnancy

Related Conditions & MeSH terms

• Pulmonary Air Leak

Intervention

Device:
• Device: Thoraguard Surgical Drainage System
Fluid drainage following thoracic surgery

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Centese, Inc.	NYU Langone Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

McGuire AL, Petrcich W, Maziak DE, Shamji FM, Sundaresan SR, Seely AJ, Gilbert S. Digital versus analogue pleural drainage phase 1: prospective evaluation of interobserver reliability in the assessment of pulmonary air leaks. Interact Cardiovasc Thorac Surg. 2015 Oct;21(4):403-7. doi: 10.1093/icvts/ivv128. Epub 2015 Jul 14. — View Citation

Miller DL, Helms GA, Mayfield WR. Digital Drainage System Reduces Hospitalization After Video-Assisted Thoracoscopic Surgery Lung Resection. Ann Thorac Surg. 2016 Sep;102(3):955-961. doi: 10.1016/j.athoracsur.2016.03.089. Epub 2016 May 25. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device User Experience Survey	The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the Thoraguard Surgical Drainage System. The questionnaire asks approximately 15 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating clinicians at the completion of the study. A summary of all treating clinician responses will be generated at the completion of the study to summarize the overall user experience with the device.	At study completion - approximate 6 months.