Deep SedationNCT05762692
High-flow Nasal Oxygenation During Deep Sedation in Pediatric Dental Patients
A study testing High-flow nasal oxygenation device in people with Deep Sedation and Dental Treatment, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Deep Sedation, Dental Treatment, Pediatric Patients
- What is being tested?
- High-flow nasal oxygenation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in need of deep sedation for dental treatment aged 3-7 years.
- anticipated operation time over 60 mins.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University of Stomatology
Beijing
Xudong Yang
About this study
Official title: 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.
- Conditions
- Deep Sedation, Dental Treatment, Pediatric Patients
- Being tested
- High-flow nasal oxygenation device
- Keywords
- high-flow nasal oxygenation, dental treatment, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow nasal oxygenation deviceDevice
The patients included will be oxygenated by HFNO device during the operation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: High-flow nasal oxygenation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
The occurrence of decreased oxygen saturation up to 90%.
Measured: Intra-operative
Secondary outcomes (6)
Severe Hypoxemia
The occurrence of decreased oxygen saturation up to 85%
Measured: Intra-operative
Desaturation
The occurrence of decreased oxygen saturation up to 94%.
Measured: Intra-operative
Intra-operative airway assistance
The need of intra-operative airway assistance maneuvers including jaw lifting, suction, mask ventilation and intubation.
Measured: Intra-operative
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.
Measured: Intra-operative
Intra-operative end-tidal carbon dioxide level
The highest intra-operative end-tidal carbon dioxide level.
Measured: Intra-operative
Intra-operative transcutaneous carbon dioxide level
The highest intra-operative transcutaneous carbon dioxide level.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Jun 2023
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep SedationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xudong, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762692
- Sponsor's protocol ID
- PKUSSIRB-202283174
- Status last verified
- Aug 2023
- First submitted
- 9 Feb 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng T, Wu XR, Liu Y, Li BH, Yang XD. Clinical feasibility of high-flow nasal oxygenation during dental procedures in pediatric patients under intravenous deep sedation: initial experience. BMC Oral Health. 2026 Jun 1. doi: 10.1186/s12903-026-08710-y. Online ahead of print.
PubMed 42219481
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Efficacy of High-flow Nasal Oxygenation During Intravenous Deep Sedation in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT05762692
- Acronym / sponsor ID
- PKUSSIRB-202283174
- Conditions
- Deep Sedation, Dental Treatment, Pediatric Patients
- Keywords
- high-flow nasal oxygenation, dental treatment, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNO Group | Experimental | Device: High-flow nasal oxygenation deviceIntra-operative oxygenation will be administered by the high-flow nasal oxygenation device. The flow rate is 2L/kg.(upper limit 30L/min) |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children in need of deep sedation for dental treatment aged 3-7 years.
- anticipated operation time over 60 mins.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow nasal oxygenation deviceThe patients included will be oxygenated by HFNO device during the operation | Device | HFNO Group |
Primary outcome
Hypoxemia
Time frame: Intra-operative
The occurrence of decreased oxygen saturation up to 90%.
6 secondary outcomes
Severe Hypoxemia
Time frame: Intra-operative
Desaturation
Time frame: Intra-operative
Intra-operative airway assistance
Time frame: Intra-operative
Operation interruption
Time frame: Intra-operative
Intra-operative end-tidal carbon dioxide level
Time frame: Intra-operative
Intra-operative transcutaneous carbon dioxide level
Time frame: Intra-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 42219481Cheng T, Wu XR, Liu Y, Li BH, Yang XD. Clinical feasibility of high-flow nasal oxygenation during dental procedures in pediatric patients under intravenous deep sedation: initial experience. BMC Oral Health. 2026 Jun 1. doi: 10.1186/s12903-026-08710-y. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flow nasal oxygenation device in people with Deep Sedation and Dental Treatment, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xudong Yang, MD (18810086060, kqyangxudong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.