Experiences With Automated Surgical Drainage in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-22

Study Completion Date

2020-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

Patients selected to participate.

Blood drainage post cardiac surgery

Intervention Type DEVICE

Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.

Interventions

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Blood drainage post cardiac surgery

Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No