High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients

Study Overview
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Brief Summary
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It is important to choose an appropriate oxygenation technique during intravenous deep sedation in pediatric dental treatment. The study is to evaluate the efficacy and safety of high-flow nasal oxygenation in intravenous deep sedation in pediatric dental patients.

Official Title
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Clinical Feasibility and Efficacy of High-flow Nasal Oxygenation During Intravenous Deep Sedation in Pediatric Dental Patients

Conditions
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Deep Sedation, Dental Treatment, Pediatric Patients

Intervention / Treatment
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* Device: High-flow nasal oxygenation device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children in need of deep sedation for dental treatment aged 3-7 years. anticipated operation time over 60 mins. Exclusion Criteria: Conditions which the attending considers to be unfit for elective surgery or tubeless anesthesia. Any contraindications of high flow nasal oxygenation. Any contraindications or allergic history of propofol.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNO Group<br>Intra-operative oxygenation will be administered by the high-flow nasal oxygenation device. The flow rate is 2L/kg.(upper limit 30L/min) | Device: High-flow nasal oxygenation device<br>* The patients included will be oxygenated by HFNO device during the operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxemia | The occurrence of decreased oxygen saturation up to 90%. | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Hypoxemia | The occurrence of decreased oxygen saturation up to 85% | Intra-operative | 
| Desaturation | The occurrence of decreased oxygen saturation up to 94%. | Intra-operative | 
| Intra-operative airway assistance | The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation. | Intra-operative | 
| Operation interruption | The occurrence of intra-operative surgical operation interruption due to decreased oxygen saturation, secretion, airway suction, severe body movement, etc., except for surgical reasons. | Intra-operative | 
| Intra-operative end-tidal carbon dioxide level | The highest intra-operative end-tidal carbon dioxide level. | Intra-operative | 
| Intra-operative transcutaneous carbon dioxide level | The highest intra-operative transcutaneous carbon dioxide level. | Intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-flow nasal oxygenation, dental treatment, children