The Effect of 3D Heart Modelling on Family Quality of Life and Surgical Success
NCT ID: NCT05852106
Last Updated: 2023-05-10
Study Results
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-07-01
2024-02-01
Brief Summary
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Methods: The study is a two-group pretest-posttest randomized controlled study. The children who come to the outpatient clinic examination in a private hospital and who are subjected to Computed Tomography (CT) examination for diagnostic procedures will be modeled in the experimental group, pre-tests will be applied, and the model will be 3D printed after it is approved by the radiologist who is among the researchers. The sample size is 15 experimental group and 15 control group. After the radiologist's approval, surgical simulation and preoperative education will be applied to the experimental group. The control group will receive the same parent education as the standard model. Both groups will complete the Sociodemographic Information Form, Surgical Simulation Evaluation Form - Part I, and Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module one week prior to hospitalization. Surgical simulation and preoperative education will be completed on the same day. On postoperative day 0, only the Surgical Simulation Evaluation Form - Part II will be applied and on postoperative day 15, the Surgical Simulation Evaluation Form - Part II and the Pediatric Quality of Life Inventory (PedsQL) Family Impacts Module will be applied to both groups as a posttest.
Pilot Study and Results: Modeling and 3D printing studies were conducted to carry out the study. A total of four diagnosed and treated patients were retrospectively analyzed. An intracardiac anomaly was detected in the patient data taken for the first model. It was decided to model the extracardiac structures since the inside of the heart was filled with blood, and the blood could not be ruled out as a solid structure. Finally, aortic coarctation was modeled clearly from the images taken and completed.
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Detailed Description
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It is predicted that 3D cardiac models obtained from patients' radiological images can be used for various purposes. It is stated that beneficial results can be obtained for multiple purposes, from planning and simulation before the definitive surgical procedure to patient-specific preoperative education. There are several techniques for modeling organs using 3D printing technology, which has developed rapidly in recent years. For the heart, two types of cardiac modeling are performed. These are filled solid models (blood pool) and hollow models. The hollow models are obtained from signals sent in a way that limits the perimeter of the area where the blood pool is located. These models are printed as a cross-section and show the intracardiac structure. However, technically, the peak heart rate of children is higher than that of adults, so the images may lose clarity, require more time and effort, and may not be as useful. Solid models have filled models of the atria and ventricles. They are typically modeled and printed from contrast-enhanced CT or MR images. Noncardiac structures can be added to these models (e.g., aorta, pulmonary artery, extracardiac vessels, trachea, and esophagus) with the goal of delineating large vessel abnormalities in the model. Extracardiac structures are very guiding in surgical simulation with easier and faster modeling than intracardiac structures. In particular, recurrent pulmonary artery stenosis and aortic coarctation can be successfully treated, and positive outcomes can be achieved with fast and patient-specific models. The operating time of surgically simulated patients is reduced, and procedures can be completed with less cost and fewer complications.
Targeted patient outcomes can be achieved by managing a multidisciplinary team that includes the patient and family and by using surgical simulation. In life-threatening diseases such as CHD, diagnosis, treatment, and surgical planning are long-term processes. This process causes serious psychological distress in parents, such as post-traumatic stress disorder. Parental/caregiver stress increases and the family's quality of life deteriorates, especially when the surgical procedure and interventions are not clearly understood. This situation negatively affects the postoperative recovery process of patients. A surgical procedure performed with good technique followed by poor postoperative management renders many interventions ineffective. Understanding the severity of the disease from the perspective of the parents can improve both the health-related quality of life of the child and the quality of life of the family, leading to more positive patient outcomes. Patient-specific modeling using 3D printing technology with images obtained through traditional methods is believed to eliminate all of these issues.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Experimental
Preoperative:Once the surgery date is set, appointments will be made with the surgeon for surgical simulation and with the family for education one week prior to surgery. The surgeon will be asked to complete the Surgical Simulation Evaluation Form-Part I. At the same time, another researcher will complete the family sociodemographic information form and PedsQL questions in the examination room. After completion of the pre-test and the surgical simulation, the families are given a 30-minute preoperative education with the "Congenital Heart Disease Parent Education Booklet", together with a life-size 3D heart model obtained from their child's own heart, and drawings on paper where they are not understood.
Postoperative: After surgery, the patient will be followed until discharge, and only Part II of the Surgical Simulation Evaluation Form will be completed. On the 15th postoperative day, the Surgical Simulation Evaluation Form Part II and the PedsQL will be given again as a posttest.
Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling
The first step in the modeling process is masking. For this study, the average minimum value for masking ventricles and large vessels was set between 80 and 200 HU (Brüning et al., 2022). Threshold values of min 216 HU - max 1502 HU are used. At these HU values, the blood in the heart and great vessels is masked and the outline of the heart is revealed. Lowering the minimum HU value is necessary to make the heart walls more visible. However, this results in masking unwanted soft tissues other than the heart, such as muscle and fat. The masked unnecessary surrounding tissues are removed first with the cropping mask and then manually by marking along the contours of the heart and great vessels. Thus, a model containing only the heart and the desired large vessels will be created and cleaned from the surrounding tissues. With this mask, 3D reconstruction will be performed, and the model will be ready for printing.
Control Group
Preoperative:When the operation date is determined, one week before the operation, the patients included in the study's control group will be asked the Sociodemographic Information Form and Pediatric Quality of Life Inventory Family Module (PedQL) questions in the examination room. After the pretest, standardized education will be given to the families. The disease process will be explained to the patients with the same 'Congenital Heart Diseases Parent Education Booklet', and the disease process will be presented with the heart model used in standard medical faculty anatomy courses and the ununderstood parts will be detailed by drawing on paper. The remaining 15 minutes of the education will be conducted as a question and answer with the parents.
Postoperative:After the operation, the Surgical Simulation Evaluation Form Part II and PedsQL will be filled out again as post-tests for this group.
No interventions assigned to this group
Interventions
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Surgical Simulation with 3D Heart Model and Parental Education with "Congenital Heart Disease Parent Education Booklet" and tailored 3D Heart Modeling
The first step in the modeling process is masking. For this study, the average minimum value for masking ventricles and large vessels was set between 80 and 200 HU (Brüning et al., 2022). Threshold values of min 216 HU - max 1502 HU are used. At these HU values, the blood in the heart and great vessels is masked and the outline of the heart is revealed. Lowering the minimum HU value is necessary to make the heart walls more visible. However, this results in masking unwanted soft tissues other than the heart, such as muscle and fat. The masked unnecessary surrounding tissues are removed first with the cropping mask and then manually by marking along the contours of the heart and great vessels. Thus, a model containing only the heart and the desired large vessels will be created and cleaned from the surrounding tissues. With this mask, 3D reconstruction will be performed, and the model will be ready for printing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Being a candidate for elective surgery,
* Having a contrast-enhanced CT image taken during and before the patient's routine diagnostic procedure outside the scope of the study,
* Having at least 15 days between the imaging and the surgical procedure plan,
Exclusion Criteria
* Emergency surgical procedures, heart defects involving intracardiac structures (Atrial Septal Defect, Ventricular Septal Defect, Tetralogy of Fallot),
* Additional anomalies/syndromes,
* Chronic diseases (such as neurodevelopmental disorders, bleeding disorders, asthma, or Down syndrome),
* History of cardiac arrest, contrast agent reflection in the images,
* Image quality preventing modeling.
0 Years
18 Years
ALL
No
Sponsors
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Yeditepe University
OTHER
Responsible Party
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Aylin Akça
Assist Prof
Principal Investigators
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AYLIN AKCA SUMENGEN, PhD
Role: PRINCIPAL_INVESTIGATOR
Yeditepe University
Locations
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Yeditepe University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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Yeditepe University Nursing
Identifier Type: -
Identifier Source: org_study_id
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