NCT05762692

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

February 9, 2023

Last Update Submit

August 2, 2023

Conditions

Deep SedationDental TreatmentPediatric Patients

Keywords

high-flow nasal oxygenationdental treatmentchildren

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

    The occurrence of decreased oxygen saturation up to 90%.

    Intra-operative

Secondary Outcomes (6)

  • Severe Hypoxemia

    Intra-operative

  • Desaturation

    Intra-operative

  • Intra-operative airway assistance

    Intra-operative

  • Operation interruption

    Intra-operative

  • Intra-operative end-tidal carbon dioxide level

    Intra-operative

  • +1 more secondary outcomes

Study Arms (1)

HFNO Group

EXPERIMENTAL

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

High-flow nasal oxygenation deviceDEVICE

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

HFNO Group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University of Stomatology

Beijing, China

RECRUITING

Central Study Contacts

Xudong Yang, MD

CONTACT

18810086060kqyangxudong@163.com

Tong Cheng, MD

CONTACT

15811229030chengtong@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Anesthesiology

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 10, 2023

Study Start

June 1, 2023

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations

CN(1)