Hemorrhage
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEBlood drainage post cardiac surgery
Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.
Sponsors
Stanford University
Centese, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device User Experience Survey | At study completion - approximate 6 months. | 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. |
Countries
United States
Outcome results
None listed