Experiences With Automated Surgical Drainage in Cardiac Surgery

Hemorrhage Clinical Trial

Official title:

Experiences With Automated Surgical Drainage in Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860363
• Other study ID #: CRD-1129
• Status: Completed
• Start date: February 22, 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 following cardiac 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, drainage kit (fluid collection canister and drainage line), and chest tube kit with novel chest tube. The system continuously monitors chest tube and drainage line patency, automatically clears the chest tube and drainage line from build-up, and provides digital readings of fluid output trends. Additionally, the system has patient safety alarms to notify clinical staff of an unexpected event associated with post-operative drainage. These functions offer significant improvements over 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 patient experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• 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 cardiac surgery

• Anticipated requirement for mediastinal chest tube drainage

Exclusion Criteria:

• Emergency surgery

• Re-do surgery

• Prior cardiac surgery

• Congenital cardiac disease or deformation

• Transplant surgery

• Ventricular Assist Device Surgery

• Suspected pulmonary air leak

• Atrial fibrillation

• 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

• Hemorrhage

Intervention

Device:
• Blood drainage post cardiac surgery
Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Centese, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Balzer F, von Heymann C, Boyle EM, Wernecke KD, Grubitzsch H, Sander M. Impact of retained blood requiring reintervention on outcomes after cardiac surgery. J Thorac Cardiovasc Surg. 2016 Aug;152(2):595-601.e4. doi: 10.1016/j.jtcvs.2016.03.086. Epub 2016 Apr 14. — View Citation

Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. Review. Erratum in: Am J Crit Care. 2008 May;17(3):193. — View Citation

Karimov JH, Gillinov AM, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surg. 2013 Dec;44(6):1029-36. doi: 10.1093/ejcts/ezt140. Epub 2013 Mar 21. — View Citation

Mahmood K, Wahidi MM. Straightening out chest tubes: what size, what type, and when. Clin Chest Med. 2013 Mar;34(1):63-71. doi: 10.1016/j.ccm.2012.11.007. Epub 2013 Jan 17. Review. — View Citation

Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x. — 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.