Status:
RECRUITING
Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
Lead Sponsor:
Brno University Hospital
Collaborating Sponsors:
Brno University of Technology
Masaryk University
Conditions:
Cleft Lip and Palate
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief 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 Repu...
Detailed Description
After approval by the Ethics Committee of the Brno University Hospital and registration at clinicaltrials.gov, the study will include patients meeting inclusive criteria for whom primary surgery for a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04422847
Start Date
August 1 2021
End Date
December 31 2026
Last Update
November 17 2025
Active Locations (1)
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1
University hospital Brno
Brno, Jihomoravská Kraj, Czechia, 62500