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

August 2, 2023 updated by: Yang Xudong, Peking University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University of Stomatology
        • Contact:
          • Xudong Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Study Population

Pediatric patients in need of deep sedation for dental treatment aged 3-7 years, without contraindications of high flow nasal oxygenation device or intravenous anesthetics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The patients included will be oxygenated by HFNO device during the operation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PKUSSIRB-202283174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Deep Sedation

Clinical Trials on High-flow nasal oxygenation device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe