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

Deep Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762692
• Other study ID #: PKUSSIRB-202283174
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Peking University
• Contact: Xudong Yang, MD
• Phone: 18810086060
• Email: kqyangxudong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Sedation
• Dental Treatment
• Pediatric Patients

Intervention

Device:
• High-flow nasal oxygenation device
The patients included will be oxygenated by HFNO device during the operation

Locations

Country	Name	City	State
China	Peking University of Stomatology	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	The occurrence of decreased oxygen saturation up to 90%.	Intra-operative
Secondary	Severe Hypoxemia	The occurrence of decreased oxygen saturation up to 85%	Intra-operative
Secondary	Desaturation	The occurrence of decreased oxygen saturation up to 94%.	Intra-operative
Secondary	Intra-operative airway assistance	The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation.	Intra-operative
Secondary	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
Secondary	Intra-operative end-tidal carbon dioxide level	The highest intra-operative end-tidal carbon dioxide level.	Intra-operative
Secondary	Intra-operative transcutaneous carbon dioxide level	The highest intra-operative transcutaneous carbon dioxide level.	Intra-operative