Experiences With Automated Surgical Drainage in Cardiac Surgery
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/3/2019 |
| Start Date: | February 22, 2019 |
| End Date: | July 31, 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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