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

RecruitingNAAges any - 2 YearsAllBrno University Hospital
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In plain words

What the trial is, and whether it could suit you

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 on

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • 3D obturator
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Where

1 site
University hospital Brno
Brno, Czechia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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