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Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect (3D Obturator) - Pilot Trial

NCT04422964 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-11

No results posted yet for this study

Summary

Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood. At the University Hospital Brno, the treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the University Hospital Brno. The main specialties that form the basis of CC include plastic surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are divided into 2 main groups based on the embryological causes of clefts: 1/ patients with cleft lip, jaw with or without cleft palate (total cleft) and 2/ patients with isolated cleft soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to the age of the patients, but mainly to the cleft itself. Anesthesiology management, and especially intubation of these patients, are often difficult due to the nature of the defect with high incidence of complications such as difficult airway, desaturation, laryngospasm or bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch, palate and nasal septum as well as skeleton of the premaxilla and nasal septum during intubation is seen in approximately 90% of patients. To facilitate intubation, improve anesthesiology management and safety of pediatric patients with orofacial cleft, investigators will develop an individualized protective tray from a silicone material, that will be used during intubation to cover the defect of the alveolar arch and palate. A mold for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of the protective tray would facilitate intubation, decrease anesthesiologic complications and protect soft and hard tissues of the cleft palate and upper jaw during intubation.

Conditions

  • Cleft Lip and Palate

Interventions

DEVICE

3D Obturator

Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer

Sponsors & Collaborators

  • Brno University of Technology

    collaborator OTHER

  • Masaryk University

    collaborator OTHER

  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Petr Štourač, prof. MD., Ph.D. · Faculty of medicince Masaryk University and University Hospital Brno

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2022-08-01
Completion
2022-09-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04422964 on ClinicalTrials.gov