Pediatric SedationNCT04852432
Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
A study testing high flow nasal cannula and nasal prong in people with Pediatric Sedation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Sedation
- What is being tested?
- high flow nasal cannula and nasal prong
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2021to 30 Dec 2024
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under the age of 18 who undergo moderate-deep sedation
Who cannot join
- Respiratory failure patients
- Increased intracranial pressure
- Recent massive nasal bleeding
- History of airway surgery
- Complete nasal obstruction
- Pulmonary hypertension
- Skull base fracture
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jin-Tae Kim, Pf., +82-2-2072-3295, jintae73@gmail.com
About this study
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.
- Conditions
- Pediatric Sedation
- Being tested
- high flow nasal cannula, nasal prong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.
nasal prongDevice
Oxygen is administered via nasal prong
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Nasal prong is applied, but sedation is performed without oxygen administration. |
| Low flow group | Experimental | Oxygen administration by nasal cannula Receives: Device: nasal prong |
| High flow group | Experimental | Oxygen is administered at a rate of 2L/kg/min using an Optiflow device Receives: Device: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation (≤95%)
Occurrence of desaturation (pulse oximeter ≤95%)
Measured: through study completion, average 30 minutes
Secondary outcomes (4)
Desaturation (≤90%)
Occurrence of desaturation (pulse oximeter ≤90%)
Measured: through study completion, average 30 minutes
CO2 value
percutaneous CO2 (maximum, minimum, mean values)
Measured: through study completion, average 30 minutes
Minimum saturation during sedation
Measured: through study completion, average 30 minutes
Complications
Any complications during sedation
Measured: through study completion, average 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start27 Jul 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2024 (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 Pediatric SedationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852432
- Sponsor's protocol ID
- H2103-095-1205
- Status last verified
- Feb 2024
- First submitted
- 15 Apr 2021
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee JH, Ko HJ, Park JB, Ji SH, Kim JT. Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial. Anesthesiology. 2025 Jul 1;143(1):132-141. doi: 10.1097/ALN.0000000000005500. Epub 2025 Apr 11.
PubMed 40215365
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Oxygen Therapy and Clinical Feasibility of High Flow Nasal Cannula During Moderate and Deep Sedation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04852432
- Acronym / sponsor ID
- H2103-095-1205
- Conditions
- Pediatric Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Apr 2021 (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.
The investigators evaluate the efficacy and safety of routine administration of oxygen during moderate or deep sedation in pediatric patients. In addition, in terms of efficacy and safety, oxygen administration via nasal prong and high flow nasal cannula will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Nasal prong is applied, but sedation is performed without oxygen administration. |
| Low flow group | Experimental | Device: nasal prongOxygen administration by nasal cannula |
| High flow group | Experimental | Device: high flow nasal cannulaOxygen is administered at a rate of 2L/kg/min using an Optiflow device |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children under the age of 18 who undergo moderate-deep sedation
Key exclusion criteria (7 listed)
- Respiratory failure patients
- Increased intracranial pressure
- Recent massive nasal bleeding
- History of airway surgery
- Complete nasal obstruction
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 cannulaThe heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%. | Device | High flow group |
| nasal prongOxygen is administered via nasal prong | Device | Low flow group |
Primary outcome
Desaturation (≤95%)
Time frame: through study completion, average 30 minutes
Occurrence of desaturation (pulse oximeter ≤95%)
4 secondary outcomes
Desaturation (≤90%)
Time frame: through study completion, average 30 minutes
CO2 value
Time frame: through study completion, average 30 minutes
Minimum saturation during sedation
Time frame: through study completion, average 30 minutes
Complications
Time frame: through study completion, average 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40215365Lee JH, Ko HJ, Park JB, Ji SH, Kim JT. Oxygen Supplementation in Pediatric Sedation: Prospective, Multicenter, Randomized Controlled Trial. Anesthesiology. 2025 Jul 1;143(1):132-141. doi: 10.1097/ALN.0000000000005500. Epub 2025 Apr 11.
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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.
Jin-Tae Kim, MD, PhD 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 cannula and nasal prong in people with Pediatric Sedation, 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 7 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 23 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Tae Kim, MD, PhD (02-2072-3661 ext. 82, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desaturation (≤95%) (time frame: through study completion, average 30 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 NCT04852432, 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 23 Feb 2024.