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

NCT04422847 | Recruiting DMC

• 1 other identifier: 3D Obturator
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip and Palate

Keywords

3D print; Cleft surgery; Paediatric; Airway

Outcome Measures

Primary Outcomes (1)

• Degree of oral tissue injury during intubation

  specifically presence of petechiae, bleeding or soft tissue swelling after intubation in the entire cleft defect area, possibly premaxilla fracture in total cleft patients as a result of manipulation of the laryngoscope in the oral cavity

  Intraoperatively (after successful intubation)

Secondary Outcomes (1)

• Cormack-Lehane score

  Intraoperatively (during intubation)

Other Outcomes (2)

• Number of intubations attempts

  Intraoperatively

• Incidence of associated complications

  Intraoperatively

Study Arms (2)

intervention group (3D protective obturator)

EXPERIMENTAL

Patients enrolled in the intervention group will have an intraoral scan of the palate, alveolar arch, and upper vestibular area before surgery. Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer, in cooperation with the Faculty of Mechanical Engineering (Department of Mechanics of Bodies, Mechatronics and Biomechanics) of Brno University of Technology. For the production of the obturator, a silicone certified for use in the oral cavity will be used.

Device: 3D obturator

control group

NO INTERVENTION

The standard procedure without the 3D obturator.

Interventions

3D obturator DEVICE

Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer

Also known as: 3D printer obturator

intervention group (3D protective obturator)

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Brno University Hospital: lead
• Brno University of Technology: collaborator
• Masaryk University: collaborator

Study Sites (1)

University hospital Brno

Brno, Jihomoravská Kraj, 62500, Czechia

RECRUITING

Related Publications (1)

• Richtrova M, Koskova O, Marcian P, Borak L, Bonischova T, Fabian D, Janku M, Joukal M, Vymazalova K, Stourac P. Customized protective palatal obturator for intubation in newborns in cleft lip surgery: a randomized controlled trial. Ann Med. 2025 Dec;57(1):2561802. doi: 10.1080/07853890.2025.2561802. Epub 2025 Sep 22.

  PMID: 40981509 DERIVED

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Petr Štourač, prof. MD., Ph.D.

  Faculty of medicince Masaryk University and University Hospital Brno

  STUDY CHAIR

Central Study Contacts

Michaela Richtorvá, MD.

CONTACT

532234693; richtrova.michaela@fnbrno.cz

Olga Košková, MD., Ph.D.

CONTACT

532234790; koskova.olga@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be included
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc.prof.MD,Ph.D

Model Details: Patient will be randomized according to the interventional and control goup according to the day of surgery. The allocation between the groups will be 1:1

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: August 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CZ (1)