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RecruitingNCT05762692Updated Aug 4, 2023

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

An interventional study of High-flow nasal oxygenation device in Deep Sedation, Dental Treatment and Pediatric Patients, sponsored by Peking University. Recruiting at 1 site in China. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Peking University · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was expected by Oct 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
3 Years to 7 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Deep Sedation
  • Dental Treatment
  • Pediatric Patients

Keywords

  • high-flow nasal oxygenation
  • dental treatment
  • children
03

In context

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    HFNO Group

    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

Interventions

  • DeviceHigh-flow nasal oxygenation device

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

06

What researchers measure

Primary outcomes

  1. Hypoxemia

    The occurrence of decreased oxygen saturation up to 90%.

    Time frame: Intra-operative

Secondary outcomes

  1. Severe Hypoxemia

    The occurrence of decreased oxygen saturation up to 85%

    Time frame: Intra-operative

  2. Desaturation

    The occurrence of decreased oxygen saturation up to 94%.

    Time frame: Intra-operative

  3. Intra-operative airway assistance

    The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation.

    Time frame: Intra-operative

  4. 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.

    Time frame: Intra-operative

  5. Intra-operative end-tidal carbon dioxide level

    The highest intra-operative end-tidal carbon dioxide level.

    Time frame: Intra-operative

  6. Intra-operative transcutaneous carbon dioxide level

    The highest intra-operative transcutaneous carbon dioxide level.

    Time frame: Intra-operative

07

Study locations

1 of 1 sites recruiting
  • Peking University of Stomatology
    Beijing, China
    • Xudong Yang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05762692
Lead sponsor
Peking University
Responsible party
Yang Xudong (Chief of Department of Anesthesiology, Peking University) — Principal investigator
First posted
Mar 10, 2023
Start date
Jun 1, 2023
Primary completion
Oct 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 4, 2023

Study contacts

Xudong Yang, MD
Contact
kqyangxudong@163.com
18810086060
Tong Cheng, MD
Contact
chengtong@foxmail.com
15811229030

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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