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Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

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ClinicalTrials.gov Identifier: NCT04788082
Recruitment Status : Withdrawn (No enrollments)
First Posted : March 9, 2021
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Phoenix Children's Hospital
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Laura Olivieri, Children's National Research Institute

Study Description
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Brief Summary:
Patient-specific, 3D printed models have been utilized in preoperative planning for many years. Among researchers and clinicians, there is a perception that preoperative exposure to 3D printed models, derived from patient images (CT or MRI), aid in procedural planning. 3D printed models for heart surgery have the potential to improve a clinician's preparedness and therefore may reduce surgically-related morbidity and mortality. This randomized clinical trial aims to evaluate whether pre-procedural planning of surgeons exposed to a patient-specific 3D printed heart model will decrease cardiopulmonary bypass time, morbidity, and mortality.

Condition or disease Intervention/treatment Phase
Double Outlet Right Ventricle Transposition of the Great Arteries Truncus Arteriosus Congenitally Corrected Transposition of the Great Arteries Diagnostic Test: 3D Printed Heart Model Not Applicable

Detailed Description:

3D imaging and rapid prototyping 3D printing technology have advanced to the point where it is feasible to marry the two to produce a patient-matched and accurate 3D model of congenital heart defects. The production of a 3D model of the heart may be particularly useful in anticipation of surgery such that the operator can plan and visualize the surgery prior to the surgical date with a physical heart he or she can manipulate in their hands.

Preliminary studies demonstrate potential for clinical impact of 3D models on patient care and patient outcomes. 3D models have long been shown to enhance education and communication of anatomy. In 2008 Kim et al reviewed 3D printed models as an emerging technology in management of congenital heart disease, and also suggests that physical models may also help enhance patients and physicians' understanding of congenital heart disease. Our group has also published on the clinical and educational value of these 3D heart models. To date, no systematic trial identifying the value of 3D models on procedural planning has been published.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Impact of Rapid Prototyping 3D Models of Congenital Heart Disease on Surgical Management
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard of care (not involving 3D printing)
Experimental: 3D Model
3D printed models (at least one rigid blood volume model and one flexible shell model) will be used for surgical planning.
 Diagnostic Test: 3D Printed Heart Model
Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.
Other Name: Rapid Prototyped Heart Model


Outcome Measures
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Primary Outcome Measures :
  1. Time under cardiopulmonary bypass [ Time Frame: peri-operative ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Up to 30 days post-operative ]
  2. Intraoperative death or intraprocedural death [ Time Frame: peri-operative ]
  3. Unexpected Cardiac arrest during or following procedure [ Time Frame: From surgical date through 30 days post-operative ]
  4. Bleeding, Requiring reoperation [ Time Frame: From surgical date through 30 days post-operative ]
  5. Sternum left open, Unplanned [ Time Frame: From surgical date through 30 days post-operative ]
  6. Unplanned cardiac reoperation [ Time Frame: From surgical date through 30 days post-operative ]
  7. Unplanned non-cardiac reoperation [ Time Frame: From surgical date through 30 days post-operative ]
  8. Mechanical circulatory support (IABP, VAD, ECMO, or CPS) [ Time Frame: From surgical date through 30 days post-operative ]
    Answer "yes"/"no"

  9. Arrhythmia necessitating pacemaker, Permanent pacemaker [ Time Frame: From surgical date through 30 days post-operative ]
  10. Renal failure (discharge dialysis) [ Time Frame: From surgical date through 30 days post-operative ]
    acute renal failure, Acute renal failure requiring dialysis at the time of hospital discharge

  11. Renal failure (temporary dialysis) [ Time Frame: From surgical date through 30 days post-operative ]
    acute renal failure, Acute renal failure requiring temporary dialysis with the need for dialysis not present at hospital discharge

  12. Renal failure (hemofiltration) [ Time Frame: From surgical date through 30 days post-operative ]
    acute renal failure, Acute renal failure requiring temporary hemofiltration with the need for dialysis not present at hospital discharge

  13. Sepsis [ Time Frame: From surgical date through 30 days post-operative ]
    Sepsis (following Society of Thoracic Surgery definition)

  14. Seizure [ Time Frame: From surgical date through 30 days post-operative ]
    Seizure (following Society of Thoracic Surgery definition)

  15. Stroke [ Time Frame: From surgical date through 30 days post-operative ]
    Stroke (following Society of Thoracic Surgery definition)

  16. Vocal cord dysfunction (possible recurrent laryngeal nerve injury) [ Time Frame: From surgical date through 30 days post-operative ]
  17. Other operative/procedural complication [ Time Frame: From surgical date through 30 days post-operative ]
    Other operative/procedural complication (following Society of Thoracic Surgery definition)

  18. Technology Assessment [ Time Frame: Preop, Periop, and up to 30 days a ]
    A survey will be given to the surgeons assessing technology acceptance of the 3D printed heart models


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:

    1. double outlet right ventricle (DORV),
    2. transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),
    3. truncus arteriosus with ventricular septal defect (TA/VSD)
    4. congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS).

  • Patient who will undergo preoperative cardiac MR or cardiac CT imaging

    a. Images will be validated by the IRC prior to inclusion

  • Written informed consent (and assent when applicable) and HIPAA authorization obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

  • Complex defects involving atrioventricular valve anomalies

    1. complete or transitional atrioventricular canal
    2. double inlet left ventricle
    3. tricuspid atresia
    4. mitral atresia
  • Defects with valve dysfunction requiring an extensive valvuloplasty

  • Patients with a contraindication to MRI scanning will be excluded unless they are referred for a cardiac CT per clinical standard of practice. These contraindications include patients with the following devices:

    1. Central nervous system aneurysm clips
    2. Implanted neural stimulator
    3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
    4. Cochlear implant
    5. Ocular foreign body (e.g. metal shavings)
    6. Implanted Insulin pump
    7. Metal shrapnel or bullet.
    8. Any contraindications to receiving IV gadolinium contrast, determined clinically
  • Subjects where MRI or CT images are acquired more than six months prior to the scheduled surgical date
  • Subjects where date of scan to date of surgery is less than 10 calendar days
  • Subjects where MRI or CT reconstruction is limited due to poor image acquisition as solely determined by the Image Reconstruction Center.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788082


Locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's National Research Institute
Phoenix Children's Hospital
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Laura Olivieri, MD Children's National Research Institute
Principal Investigator: Stephen Pophal, MD Phoenix Children's Hospital
Principal Investigator: Yoav Dori, MD Children's Hospital of Philadelphia
More Information
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Additional Information:

Publications:
Cardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.
Davis FD, Bagozzi RP, Warshaw PR. User Acceptance of Computer Technology: A Comparison of Two Theoretical Models. Management Science 35(8): 982-1003, 1989.
Does RJMM, Vermaat TMB, Verver JPS, Bisgaard S, Van Den Heuvel J. Reducing Start Time Delays in Operating Rooms. Journal of Quality Technology 41(1): 95-109, 2009.
Ejaz F, Ryan J, Henriksen M, Stomski L, Feith M, Osborn M, Pophal S, Richardson R, Frakes D. Color-coded patient-specific physical models of congenital heart disease. Rapid Prototyping Journal 20(4): 336-343, 2014.
King WR, He J. A meta-analysis of the technology acceptance model. Information & Management 43(6): 740-755, 2006.
Mavroudis C, Backer C, Idriss RF. Pediatric Cardiac Surgery, 4 edition. Hoboken, NJ, Wiley-Blackwell, 2012.
Moreno Cegarra JL, Cegarra Navarro JG, Córdoba Pachón JR. Applying the technology acceptance model to a Spanish City Hall. International Journal of Information Management 34(4): 437-445, 2014.

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Responsible Party: Laura Olivieri, Cardiologist, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT04788082    
Other Study ID Numbers: 15-090
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Olivieri, Children's National Research Institute:
3D Printing
Rapid prototpying
Additional relevant MeSH terms:
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Transposition of Great Vessels
Double Outlet Right Ventricle
Congenitally Corrected Transposition of the Great Arteries
Situs Inversus
Congenital Abnormalities
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Heart Septal Defects, Ventricular
Heart Septal Defects