- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04422847
Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect (3D obturator)
Study Overview
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 cleft facial defect will be indicated.
Patients will be divided into two groups based on the type of surgery. Group 1 will include 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. Group 2 will include patients with isolated cleft palate (ICP) and patients with U/BCLAP who underwent primary cleft reconstruction between 6 and 18 months of age.
Patients in the pediatric plastic surgery clinic of the Department of Pediatric Surgery, Orthopedics and Traumatology will be randomized with a 1:1 allocation based on the day of operation to the intervention group (3D protective obturator) and the control group (standard procedure without the 3D obturator). 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.
The main objective of the research will be to find out how the use of a protective obturator (splint) will improve the protection of tissues at the cleft site and whether intubation will be facilitated in pediatric patients with orofacial clefts with congenital atypical anatomical conditions in the oral cavity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michaela Richtorvá, MD.
- Phone Number: 00420 532234693
- Email: richtrova.michaela@fnbrno.cz
Study Contact Backup
- Name: Olga Košková, MD., Ph.D.
- Phone Number: 00420 532234790
- Email: koskova.olga@fnbrno.cz
Study Locations
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Jihomoravská Kraj
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Brno, Jihomoravská Kraj, Czechia, 62500
- Recruiting
- University Hospital Brno
-
Contact:
- Petr Štourač, doc.MD.Ph.D
- Phone Number: 00420 532234404
- Email: stourac.petr@fnbrno.cz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention group (3D protective obturator)
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.
|
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
Other Names:
|
No Intervention: control group
The standard procedure without the 3D obturator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of oral tissue injury during intubation
Time Frame: Intraoperatively (after successful 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
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Intraoperatively (after successful intubation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cormack-Lehane score
Time Frame: Intraoperatively (during intubation)
|
evaluation of the laryngoscopic image during intubation evaluated by the Cormack-Lehane score with or without the use of the protective tray.
Cormack-Lehane scale range from 1 (ideal view - vocal cords) to 4 (the worst view of aditus laryngis, only the soft palate visible).
For proper archiving of the intubation process, a photodocumentation of the laryngoscopic image during intubation will be taken for each patient using a video laryngoscope.
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Intraoperatively (during intubation)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of intubations attempts
Time Frame: Intraoperatively
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The number of intubation attempts to secure the airways (first successful intubation = first wave of end-tidal CO2) with and without the use of the protective tray will be evaluated
|
Intraoperatively
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Incidence of associated complications
Time Frame: Intraoperatively
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The incidence of associated complications during induction of anesthesia - laryngospasm, bradycardia, severe desaturation < 80 % oxygen saturation oxygen saturation by pulse oximetry pulse oximetry - SpO2 will be assessed
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Intraoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3D Obturator
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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