3D-printed protective obturators to aid anesthesia for infants with cleft lip and palate
Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect
This trial will test whether custom 3D-printed intraoral obturators made from a preoperative scan can make intubation safer and easier for infants and young children having primary cleft lip or palate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Brno University Hospital Academic / other |
| Locations | 1 site (Brno, Jihomoravská Kraj) |
| Trial ID | NCT04422847 on ClinicalTrials.gov |
What this trial studies
This single-center, randomized intervention will enroll pediatric patients undergoing primary repair for cleft lip, alveolus, and/or palate and assign them 1:1 by day of operation to receive either a custom 3D-printed protective obturator used during intubation or the standard airway management without the obturator. For the intervention arm, clinicians will obtain an intraoral scan before surgery, design a negative impression, and produce a patient-specific obturator by 3D printing and casting. Patients are categorized by type and timing of repair (neonatal lip repair versus later palate or combined repairs) and follow standard anesthesiology monitoring and outcome collection. The trial focuses on peri-intubation airway management, device fit, and immediate anesthetic safety endpoints in a pediatric cleft center.
Who should consider this trial
Good fit: Infants and young children scheduled for primary cleft lip, alveolus, and/or palate repair within the specified age windows who do not have syndromic or other excluded anomalies are ideal candidates.
Not a fit: Children with isolated cleft lip without alveolar involvement, those with syndromic diagnoses or other congenital anomalies affecting anesthesia (e.g., choanal atresia), atypical clefts, or those who had primary repair outside the allowed age windows are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the approach could reduce airway trauma and make intubation quicker and safer for infants with cleft defects during primary repair.
How similar studies have performed: While 3D printing has been used successfully for surgical planning and dental appliances, the use of custom 3D obturators specifically to facilitate pediatric intubation in cleft patients is relatively novel with limited published data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brno, Jihomoravská Kraj
- University hospital Brno — Brno, Jihomoravská Kraj, Czechia (Recruiting)
Study contacts
- Study coordinator: Michaela Richtorvá, MD.
- Email: richtrova.michaela@fnbrno.cz
- Phone: 532234693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.