NCT04422847 Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
| NCT ID | NCT04422847 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brno University Hospital |
| Condition | Cleft Lip and Palate |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2021-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2021-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Petr Štourač, prof. MD., Ph.D.
STUDY CHAIR
Faculty of medicince Masaryk University and University Hospital Brno
Frequently Asked Questions
Who can join the NCT04422847 clinical trial?
This trial is open to participants of all sexes, up to 2 Years, studying Cleft Lip and Palate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04422847 currently recruiting?
Yes, NCT04422847 is actively recruiting participants. Contact the research team at richtrova.michaela@fnbrno.cz for enrollment information.
Where is the NCT04422847 trial being conducted?
This trial is being conducted at Brno, Czechia.
Who is sponsoring the NCT04422847 clinical trial?
NCT04422847 is sponsored by Brno University Hospital. The principal investigator is Petr Štourač, prof. MD., Ph.D. at Faculty of medicince Masaryk University and University Hospital Brno. The trial plans to enroll 120 participants.