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

Not Applicable

Recruiting

• Conditions: Dental Treatment; Pediatric Patients; Deep Sedation
• Interventions: Device: High-flow nasal oxygenation device

• Registration Number: NCT05762692
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Study Start: 2023-06-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time over 60 mins.

Exclusion Criteria

1. Conditions which the attending considers to be unfit for elective surgery or tubeless anesthesia.
2. Any contraindications of high flow nasal oxygenation.
3. Any contraindications or allergic history of propofol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFNO Group	High-flow nasal oxygenation device	Intra-operative oxygenation will be administered by the high-flow nasal oxygenation device. The flow rate is 2L/kg.(upper limit 30L/min)

Primary Outcome Measures

Name	Time	Method
Hypoxemia	Intra-operative	The occurrence of decreased oxygen saturation up to 90%.

Secondary Outcome Measures

Name	Time	Method
Severe Hypoxemia	Intra-operative	The occurrence of decreased oxygen saturation up to 85%
Intra-operative airway assistance	Intra-operative	The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation.
Desaturation	Intra-operative	The occurrence of decreased oxygen saturation up to 94%.
Intra-operative transcutaneous carbon dioxide level	Intra-operative	The highest intra-operative transcutaneous carbon dioxide level.
Operation interruption	Intra-operative	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 end-tidal carbon dioxide level	Intra-operative	The highest intra-operative end-tidal carbon dioxide level.

Trial Locations

Locations (1)

Peking University of Stomatology; 🇨🇳 Beijing, China