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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05762692

Enrollment

Registered

2023-03-10

Start date

2023-06-01

Completion date

2023-12-31

Last updated

2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sedation, Dental Treatment, Pediatric Patients

Keywords

high-flow nasal oxygenation, dental treatment, children

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.

Interventions

DEVICEHigh-flow nasal oxygenation device

The patients included will be oxygenated by HFNO device during the operation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 7 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactXudong Yang, MD

kqyangxudong@163.com18810086060

Backup ContactTong Cheng, MD

chengtong@foxmail.com15811229030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026