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

NCT ID: NCT05762692

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Deep Sedation Dental Treatment Pediatric Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

High-flow nasal oxygenation device

Intervention Type DEVICE

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

Interventions

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High-flow nasal oxygenation device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Yang Xudong

Chief of Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University of Stomatology

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xudong Yang, MD

Role: CONTACT

18810086060

Tong Cheng, MD

Role: CONTACT

15811229030

Facility Contacts

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Xudong Yang

Role: primary

Other Identifiers

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PKUSSIRB-202283174

Identifier Type: -

Identifier Source: org_study_id

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