Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect

Recruiting now · Not applicable

Conditions studied: Cleft Lip and Palate

In brief

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, we 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.

Key facts

Study ID: NCT04422847
Run by: Brno University Hospital
People needed: 120
Starts: 2021-08-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-11-17

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Pediatric patients with unilateral or bilateral cleft lip and alveolus (U/BCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U/BCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period)
Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U/BCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age.

You may not qualify if…

unilateral or bilateral cleft lip without cleft alveolus
patients with genetically confirmed syndrome disability
orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae)
patients with atypical clefts of the face
patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age
patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18 months of age
patients with submucous cleft palate
patients with airways secured preoperatively
patients on artificial lung ventilation
patients with coagulopathy, thrombocytopenia/thrombocytopathy
patients at risk of malignant hyperthermia
patients for whom the consent of legal representatives to the research project has not been obtained

Where it is running

University hospital Brno — Brno, Jihomoravská Kraj, Czechia (enrolling)

Full record on ClinicalTrials.gov

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