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

P

Peking University

Status

Enrolling

Conditions

Dental Treatment
Deep Sedation
Pediatric Patients

Treatments

Device: High-flow nasal oxygenation device

Study type

Interventional

Funder types

Other

Identifiers

NCT05762692
PKUSSIRB-202283174

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

3 to 7 years old

Volunteers

No 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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

HFNO Group
Experimental group
Description:
Intra-operative oxygenation will be administered by the high-flow nasal oxygenation device. The flow rate is 2L/kg.(upper limit 30L/min)
Treatment:
Device: High-flow nasal oxygenation device

Trial contacts and locations

1

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Central trial contact

Tong Cheng, MD; Xudong Yang, MD

Data sourced from clinicaltrials.gov

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