Experiences With Automated Surgical Drainage in Cardiac Surgery

Hemorrhage Clinical Trial

Official title: Experiences With Automated Surgical Drainage in Cardiac Surgery

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hemorrhage

• NCT number: NCT03860363
• Study type: Observational
• Source: Centese, Inc.
• Status: Completed
• Start date: February 22, 2019
• Completion date: May 30, 2020