Experiences With Automated Surgical Drainage in Cardiac Surgery
Experiences With Automated Surgical Drainage in Cardiac Surgery
Sponsors
Source
Centese, Inc.
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
Yes
Is Unapproved Device
No
Is Ppsd
No
Is Us Export
No
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.
Overall Status
Enrolling by invitation
Start Date
2019-02-22
Completion Date
2019-12-31
Primary Completion Date
2019-11-30
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Device User Experience Survey |
At study completion - approximate 6 months. |
Number Of Groups
1
Enrollment
30
Condition
Intervention
Intervention Type
Device
Intervention Name
Description
Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.
Arm Group Label
Treatment Group
Eligibility
Study Pop
Non-emergent cardiac surgery patients undergoing one of the following procedures: coronary
artery bypass grafting, aortic valve repair or replacement, mitral valve repair or
replacement, ascending aortic surgery, a combination of these procedures, or in conjunction
with additional procedures such as left ventricular aneurysm repair.
Sampling Method
Non-Probability Sample
Criteria
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jack Boyd, MD |
Principal Investigator |
Stanford University |
Location
Facility |
|
Stanford University Stanford California 94305 United States |
Location Countries
Country
United States
Verification Date
2019-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Treatment Group
Description
Patients selected to participate.
Firstreceived Results Date
N/A
Reference
Citation
Karimov JH, Gillinov AM, Schenck L, Cook M, Kosty Sweeney D, Boyle EM, Fukamachi K. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surg. 2013 Dec;44(6):1029-36. doi: 10.1093/ejcts/ezt140. Epub 2013 Mar 21.
PMID
23520232
Citation
Balzer F, von Heymann C, Boyle EM, Wernecke KD, Grubitzsch H, Sander M. Impact of retained blood requiring reintervention on outcomes after cardiac surgery. J Thorac Cardiovasc Surg. 2016 Aug;152(2):595-601.e4. doi: 10.1016/j.jtcvs.2016.03.086. Epub 2016 Apr 14.
PMID
27210474
Citation
Halm MA. To strip or not to strip? Physiological effects of chest tube manipulation. Am J Crit Care. 2007 Nov;16(6):609-12. Review. Erratum in: Am J Crit Care. 2008 May;17(3):193.
PMID
17962505
Citation
Mahmood K, Wahidi MM. Straightening out chest tubes: what size, what type, and when. Clin Chest Med. 2013 Mar;34(1):63-71. doi: 10.1016/j.ccm.2012.11.007. Epub 2013 Jan 17. Review.
PMID
23411057
Citation
Shalli S, Saeed D, Fukamachi K, Gillinov AM, Cohn WE, Perrault LP, Boyle EM. Chest tube selection in cardiac and thoracic surgery: a survey of chest tube-related complications and their management. J Card Surg. 2009 Sep-Oct;24(5):503-9. doi: 10.1111/j.1540-8191.2009.00905.x.
PMID
19740284
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
February 27, 2019
Study First Submitted Qc
February 28, 2019
Study First Posted
March 1, 2019
Last Update Submitted
August 22, 2019
Last Update Submitted Qc
August 22, 2019
Last Update Posted
August 26, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.