Oxygen DeficiencyNCT05578131
High-flow Nasal Cannula for Pediatric Anesthetic Induction
A study testing high flow nasal oxygen and face mask in people with Oxygen Deficiency, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during… Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- high flow nasal oxygen and face mask
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Oct 2022to 2 May 2025
- 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 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants undergoing general anesthesia with endotracheal intubation.
Who cannot join
- infants who diagnosed as cardiorespiratory problem preoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial
Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.
The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 132 patients undergoing elective surgery aged <=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.
- Conditions
- Oxygen Deficiency
- Being tested
- high flow nasal oxygen, face mask
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal oxygenProcedure or surgery
In the intervention group, pre-oxygenation was provided using HFNO via Optiflow THRIVE™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) until SpO2 on pulse oximetry was > 95% and for at least 3 min. A flow of 0.5 l/kg/min-1 was used until induction agents had been administered, and then increased to 2 l/kg/min-1. Nasal oxygenation was continued without ventilation of the lungs while waiting for neuromuscular blockade, and during placing, replacing or repositioning the airway. Anaesthetists were free to carry out bag-mask ventilation of the lungs if they considered this necessary to maintain safe oxygen saturations. After securing the airway, the patient was connected to a circle circuit primed with 100% oxygen and the FIO2 was continued at 100% for a period of at least five more minutes. Relevant times were recorded, including start of pre-oxygenation and start of induction of anaesthesia.
face maskProcedure or surgery
In the control group, pre-oxygenation was provided using 100% oxygen via a sealed facemask and a circle-absorber anaesthetic circuit primed with 100% oxygen by installing a ventilation bag to the mouthpiece filter and ventilating the circuit with 100% oxygen. Anaesthetists were free to carry out bag-mask ventilation of the lungs once induction medications had been administered.
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal oxygen | Experimental | Not described Receives: Procedure: high flow nasal oxygen |
| face mask | Active comparator | Not described Receives: Procedure: face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of oxygen desaturation <95%
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary outcomes (9)
Occurrence of oxygen desaturation <90%
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the lowest oxygen saturation
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the changes in oxygen reserve index
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETCO2 in first breath after intubation
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETO2 in first breath after intubation
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attempts
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Intubation times
time required to securing the airway.
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of rescue bag mask ventilation
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of gastric insufflation
Measured: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start21 Oct 2022
- Primary completion2 May 2025
- Study completion2 May 2025
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 Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-hee Kim, Seoul National University Hospital
- Investigators
- Eun-hee Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578131
- Sponsor's protocol ID
- 2209-089-1359
- Status last verified
- Jun 2025
- First submitted
- 10 Oct 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park JB, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. High-flow Nasal Oxygenation in Infants Undergoing Tracheal Intubation: A Single-center Randomized Controlled Trial. Anesthesiology. 2026 May 1;144(5):1105-1113. doi: 10.1097/ALN.0000000000005946. Epub 2026 Jan 20.
PubMed 41557566
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT05578131
- Acronym / sponsor ID
- 2209-089-1359
- Conditions
- Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 13 Oct 2022 (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.
Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.
The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 132 patients undergoing elective surgery aged <=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal oxygen | Experimental | Procedure: high flow nasal oxygen |
| face mask | Active comparator | Procedure: face mask |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants undergoing general anesthesia with endotracheal intubation.
Key exclusion criteria (1 listed)
- infants who diagnosed as cardiorespiratory problem preoperatively.
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 oxygenIn the intervention group, pre-oxygenation was provided using HFNO via Optiflow THRIVE™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) until SpO2 on pulse oximetry was > 95% and for at least 3 min. A flow of 0.5 l/kg/min-1 was used until induction agents had been administered, and then increased to 2 l/kg/min-1. Nasal oxygenation was continued without ventilation of the lungs while waiting for neuromuscular blockade, and during placing, replacing or repositioning the airway. Anaesthetists were free to carry out bag-mask ventilation of the lungs if they considered this necessary to maintain safe oxygen saturations. After securing the airway, the patient was connected to a circle circuit primed with 100% oxygen and the FIO2 was continued at 100% for a period of at least five more minutes. Relevant times were recorded, including start of pre-oxygenation and start of induction of anaesthesia. | Procedure or surgery | high flow nasal oxygen |
| face maskIn the control group, pre-oxygenation was provided using 100% oxygen via a sealed facemask and a circle-absorber anaesthetic circuit primed with 100% oxygen by installing a ventilation bag to the mouthpiece filter and ventilating the circuit with 100% oxygen. Anaesthetists were free to carry out bag-mask ventilation of the lungs once induction medications had been administered. | Procedure or surgery | face mask |
Primary outcome
Occurrence of oxygen desaturation <95%
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
9 secondary outcomes
Occurrence of oxygen desaturation <90%
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the lowest oxygen saturation
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
the changes in oxygen reserve index
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETCO2 in first breath after intubation
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
ETO2 in first breath after intubation
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Number of intubation attempts
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Intubation times
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of rescue bag mask ventilation
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Occurrence of gastric insufflation
Time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Derived from this study: PubMed 41557566Park JB, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS, Kim EH. High-flow Nasal Oxygenation in Infants Undergoing Tracheal Intubation: A Single-center Randomized Controlled Trial. Anesthesiology. 2026 May 1;144(5):1105-1113. doi: 10.1097/ALN.0000000000005946. Epub 2026 Jan 20.
- 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.
Eun-hee Kim principal investigator
Seoul National University Hospital
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 oxygen and face mask in people with Oxygen Deficiency, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jun 2025. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of oxygen desaturation <95% (time frame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.). 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 NCT05578131, 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 18 Jun 2025.