Experiences With Automated Surgical Drainage in Cardiac Surgery

Completed

• Conditions: Hemorrhage
• Interventions: Device: Blood drainage post cardiac surgery

• Registration Number: NCT03860363
• Lead Sponsor: Centese, Inc.

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.

Study Timeline

• Study Start: 2019-02-22
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-05-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Blood drainage post cardiac surgery	Patients selected to participate.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States