Clinical Impact of Rapid Prototyping 3D Models for Surgical Management

NCT04788082 | Withdrawn DMC

• 1 other identifier: 15-090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Double Outlet Right Ventricle; Transposition of the Great Arteries; Truncus Arteriosus; Congenitally Corrected Transposition of the Great Arteries

Keywords

3D Printing; Rapid prototpying

Outcome Measures

Primary Outcomes (1)

• Time under cardiopulmonary bypass

  peri-operative

Secondary Outcomes (18)

• Mortality

  Up to 30 days post-operative

• Intraoperative death or intraprocedural death

  peri-operative

• Unexpected Cardiac arrest during or following procedure

  From surgical date through 30 days post-operative

• Bleeding, Requiring reoperation

  From surgical date through 30 days post-operative

• Sternum left open, Unplanned

  From surgical date through 30 days post-operative

Study Arms (2)

Control

NO INTERVENTION

Standard of care (not involving 3D printing)

3D Model

EXPERIMENTAL

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

Interventions

3D Printed Heart Model DIAGNOSTIC_TEST

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.

Also known as: Rapid Prototyped Heart Model

3D Model

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric subjects undergoing primary complex two-ventricle repair of congenital heart defect, including but not limited to:
• double outlet right ventricle (DORV),
• transposition of the great arteries with ventricular septal defect and pulmonary stenosis (TGA/VSD/PS),
• truncus arteriosus with ventricular septal defect (TA/VSD)
• congenitally corrected transposition of the arteries with pulmonary stenosis (CCTGA/PS).
• Patient who will undergo preoperative cardiac MR or cardiac CT imaging
• 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.

You may not qualify if:

• Complex defects involving atrioventricular valve anomalies
• complete or transitional atrioventricular canal
• double inlet left ventricle
• tricuspid atresia
• 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:
• Central nervous system aneurysm clips
• Implanted neural stimulator
• Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
• Cochlear implant
• Ocular foreign body (e.g. metal shavings)
• Implanted Insulin pump
• Metal shrapnel or bullet.
• Any contraindications to receiving IV gadolinium contrast, determined clinically

Sponsors & Collaborators

• Children's National Research Institute: lead
• Phoenix Children's Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator

Study Sites (3)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (24)

• Cardoen B, Demeulemeester E, Beliën J. Operating room planning and scheduling: A literature review. European Journal of Operational Research 201(3): 921-932, 2010.

  BACKGROUND

• Costello JP, Olivieri LJ, Krieger A, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Utilizing Three-Dimensional Printing Technology to Assess the Feasibility of High-Fidelity Synthetic Ventricular Septal Defect Models for Simulation in Medical Education. World J Pediatr Congenit Heart Surg. 2014 Jul;5(3):421-6. doi: 10.1177/2150135114528721.

  PMID: 24958045 BACKGROUND

• Costello JP, Olivieri LJ, Su L, Krieger A, Alfares F, Thabit O, Marshall MB, Yoo SJ, Kim PC, Jonas RA, Nath DS. Incorporating three-dimensional printing into a simulation-based congenital heart disease and critical care training curriculum for resident physicians. Congenit Heart Dis. 2015 Mar-Apr;10(2):185-90. doi: 10.1111/chd.12238. Epub 2014 Nov 11.

  PMID: 25385353 BACKGROUND

• Cui X, Boland T, D'Lima DD, Lotz MK. Thermal inkjet printing in tissue engineering and regenerative medicine. Recent Pat Drug Deliv Formul. 2012 Aug;6(2):149-55. doi: 10.2174/187221112800672949.

  PMID: 22436025 BACKGROUND

• Davis FD, Bagozzi RP, Warshaw PR. User Acceptance of Computer Technology: A Comparison of Two Theoretical Models. Management Science 35(8): 982-1003, 1989.

  BACKGROUND

• Dexter F, Macario A. Changing allocations of operating room time from a system based on historical utilization to one where the aim is to schedule as many surgical cases as possible. Anesth Analg. 2002 May;94(5):1272-9, table of contents. doi: 10.1097/00000539-200205000-00042.

  PMID: 11973204 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Gelijns AC, Moskowitz AJ, Acker MA, Argenziano M, Geller NL, Puskas JD, Perrault LP, Smith PK, Kron IL, Michler RE, Miller MA, Gardner TJ, Ascheim DD, Ailawadi G, Lackner P, Goldsmith LA, Robichaud S, Miller RA, Rose EA, Ferguson TB Jr, Horvath KA, Moquete EG, Parides MK, Bagiella E, O'Gara PT, Blackstone EH; Cardiothoracic Surgical Trials Network (CTSN). Management practices and major infections after cardiac surgery. J Am Coll Cardiol. 2014 Jul 29;64(4):372-81. doi: 10.1016/j.jacc.2014.04.052.

  PMID: 25060372 BACKGROUND

• Hu A, Wilson T, Ladak H, Haase P, Doyle P, Fung K. Evaluation of a three-dimensional educational computer model of the larynx: voicing a new direction. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):315-22.

  PMID: 20470679 BACKGROUND

• Kim MS, Hansgen AR, Wink O, Quaife RA, Carroll JD. Rapid prototyping: a new tool in understanding and treating structural heart disease. Circulation. 2008 May 6;117(18):2388-94. doi: 10.1161/CIRCULATIONAHA.107.740977.

  PMID: 18458180 BACKGROUND

• King WR, He J. A meta-analysis of the technology acceptance model. Information & Management 43(6): 740-755, 2006.

  BACKGROUND

• Kutty S, Graney BA, Khoo NS, Li L, Polak A, Gribben P, Hammel JM, Smallhorn JF, Danford DA. Serial assessment of right ventricular volume and function in surgically palliated hypoplastic left heart syndrome using real-time transthoracic three-dimensional echocardiography. J Am Soc Echocardiogr. 2012 Jun;25(6):682-9. doi: 10.1016/j.echo.2012.02.008. Epub 2012 Mar 14.

  PMID: 22421029 BACKGROUND

• Lang RM, Badano LP, Tsang W, Adams DH, Agricola E, Buck T, Faletra FF, Franke A, Hung J, de Isla LP, Kamp O, Kasprzak JD, Lancellotti P, Marwick TH, McCulloch ML, Monaghan MJ, Nihoyannopoulos P, Pandian NG, Pellikka PA, Pepi M, Roberson DA, Shernan SK, Shirali GS, Sugeng L, Ten Cate FJ, Vannan MA, Zamorano JL, Zoghbi WA; American Society of Echocardiography; European Association of Echocardiography. EAE/ASE recommendations for image acquisition and display using three-dimensional echocardiography. J Am Soc Echocardiogr. 2012 Jan;25(1):3-46. doi: 10.1016/j.echo.2011.11.010. No abstract available.

  PMID: 22183020 BACKGROUND

• Mavroudis C, Backer C, Idriss RF. Pediatric Cardiac Surgery, 4 edition. Hoboken, NJ, Wiley-Blackwell, 2012.

  BACKGROUND

• 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.

  BACKGROUND

• Mottl-Link S, Hubler M, Kuhne T, Rietdorf U, Krueger JJ, Schnackenburg B, De Simone R, Berger F, Juraszek A, Meinzer HP, Karck M, Hetzer R, Wolf I. Physical models aiding in complex congenital heart surgery. Ann Thorac Surg. 2008 Jul;86(1):273-7. doi: 10.1016/j.athoracsur.2007.06.001.

  PMID: 18573436 BACKGROUND

• O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.

  PMID: 497341 BACKGROUND

• Olivieri L, Krieger A, Chen MY, Kim P, Kanter JP. 3D heart model guides complex stent angioplasty of pulmonary venous baffle obstruction in a Mustard repair of D-TGA. Int J Cardiol. 2014 Mar 15;172(2):e297-8. doi: 10.1016/j.ijcard.2013.12.192. Epub 2014 Jan 8. No abstract available.

  PMID: 24447757 BACKGROUND

• Ryan JR, Moe TG, Richardson R, Frakes DH, Nigro JJ, Pophal S. A novel approach to neonatal management of tetralogy of Fallot, with pulmonary atresia, and multiple aortopulmonary collaterals. JACC Cardiovasc Imaging. 2015 Jan;8(1):103-104. doi: 10.1016/j.jcmg.2014.04.030. Epub 2014 Nov 12. No abstract available.

  PMID: 25457761 BACKGROUND

• Sodian R, Weber S, Markert M, Rassoulian D, Kaczmarek I, Lueth TC, Reichart B, Daebritz S. Stereolithographic models for surgical planning in congenital heart surgery. Ann Thorac Surg. 2007 May;83(5):1854-7. doi: 10.1016/j.athoracsur.2006.12.004.

  PMID: 17462413 BACKGROUND

• Weidenbach M, Razek V, Wild F, Khambadkone S, Berlage T, Janousek J, Marek J. Simulation of congenital heart defects: a novel way of training in echocardiography. Heart. 2009 Apr;95(8):636-41. doi: 10.1136/hrt.2008.156919. Epub 2009 Jan 8.

  PMID: 19131439 BACKGROUND

• Wypij D, Newburger JW, Rappaport LA, duPlessis AJ, Jonas RA, Wernovsky G, Lin M, Bellinger DC. The effect of duration of deep hypothermic circulatory arrest in infant heart surgery on late neurodevelopment: the Boston Circulatory Arrest Trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1397-403. doi: 10.1016/s0022-5223(03)00940-1.

  PMID: 14666011 BACKGROUND

• Yarbrough AK, Smith TB. Technology acceptance among physicians: a new take on TAM. Med Care Res Rev. 2007 Dec;64(6):650-72. doi: 10.1177/1077558707305942. Epub 2007 Aug 23.

  PMID: 17717378 BACKGROUND

Related Links

• Phoenix Children's Hospital's 3D Print Lab
• Children's National Medical Center

MeSH Terms

Conditions

Double Outlet Right Ventricle; Transposition of Great Vessels; Truncus Arteriosus, Persistent; Congenitally Corrected Transposition of the Great Arteries

Condition Hierarchy (Ancestors)

Heart Septal Defects, Ventricular; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortopulmonary Septal Defect

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: March 9, 2021
• Study Start: May 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)