Induction of General AnesthesiaNCT06204653
Effect of High-flow Nasal Oxygenation on Gastric Insufflation in Children
A study testing HFNO group and MV group in people with Induction of General Anesthesia, run by Ajou University School of Medicine.
Trial summary
This is a randomized controlled study to compare the incidence of gastric insufflation when using high-flow nasal oxygenation and facemask ventilation in pediatric patients. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Induction of General Anesthesia
- What is being tested?
- HFNO group and MV group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2024to 31 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 1 to 6 years
- American Society of Anesthesiologists physical classification 1 or 2
- Scheduled for general anesthesia
Who cannot join
- Patients expected to have difficulty with mask ventilation
- Patients with oropharyngeal facial deformity
- Obese patients (BMI>30 kg/m2)
- Patients with an upper respiratory tract infection
- Patients with a history of abdominal surgery
About this study
Official title: The Effect of High-flow Nasal Oxygenation Versus Mask Ventilation on Gastric Insufflation in Children: A Randomized Controlled Trial
This is a randomized controlled study to compare the incidence of gastric insufflation when using high-flow nasal oxygenation and facemask ventilation in pediatric patients.
- Conditions
- Induction of General Anesthesia
- Being tested
- HFNO group, MV group
- Keywords
- High flow nasal oxygenation, Facemask ventilation, Gastric insufflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNO groupDevice
Also called Optiflow
100% oxygen supplied in proportion to body weight using the Optiflow THRIVETM system while maintaining jaw thrust. (0-12 kg; 2 L/kg/min, 13-15 kg; 30 L/min, 16-30 kg; 35 L/min, 31-50 kg; 40 L/min)
MV groupDevice
Mask ventilation using the one-hand E-C clamp technique and oropharyngeal airway (fresh gas flow 3 l/min, 100% O2, tidal volume 8-10 ml/kg, respiratory rate 20/min, I:E ratio 1:2, pop-off valve 13 cmH2O).
| Study group | Role | What they receive |
|---|---|---|
| High-flow nasal oxygenation group (HFNO group) | Experimental | Not described Receives: Device: HFNO group |
| Facemask ventilation group (MV group) | Active comparator | Not described Receives: Device: MV group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric insufflation
Incidence of gastric insufflation detected by gastric ultrasound (acoustic shadow phenomenon or comet-tail artifact in the antrum) or by epigastric auscultation (typical 'gurgling' or 'whoosh' sound)
Measured: From the start of anesthesia induction to 3 minutes after anesthesia induction
Secondary outcomes (5)
Gastric insufflation detected by ultrasound
Presence of acoustic shadow phenomenon or comet-tail artifact detected by ultrasound
Measured: 3 minutes after anesthesia induction
Gastric insufflation detected by auscultation
Presence of 'gurgling' or 'whoosh' sound detected by auscultation of the epigastrium.
Measured: From the start of anesthesia induction to 3 minutes after anesthesia induction
gastric antrum longitudinal diameter (D1)
gastric antrum longitudinal diameter (D1) measured by ultrasound
Measured: 3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2)
gastric antrum anteroposterior diameter (D2) measured by ultrasound
Measured: 3 minutes after anesthesia induction
gastric antral cross-sectional area (CSA)
gastric antral cross-sectional area (CSA) measured by ultrasound (CSA = (D1 Ⅹ D2 Ⅹ π)/4)
Measured: 3 minutes after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start2 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of General AnesthesiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204653
- Sponsor's protocol ID
- AJOUIRB-IV-2023-584
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-flow Nasal Oxygenation Versus Mask Ventilation on Gastric Insufflation in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06204653
- Acronym / sponsor ID
- AJOUIRB-IV-2023-584
- Conditions
- Induction of General Anesthesia
- Keywords
- High flow nasal oxygenation, Facemask ventilation, Gastric insufflation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 2 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
This is a randomized controlled study to compare the incidence of gastric insufflation when using high-flow nasal oxygenation and facemask ventilation in pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal oxygenation group (HFNO group) | Experimental | Device: HFNO group |
| Facemask ventilation group (MV group) | Active comparator | Device: MV group |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aged 1 to 6 years
- American Society of Anesthesiologists physical classification 1 or 2
- Scheduled for general anesthesia
Key exclusion criteria (5 listed)
- Patients expected to have difficulty with mask ventilation
- Patients with oropharyngeal facial deformity
- Obese patients (BMI>30 kg/m2)
- Patients with an upper respiratory tract infection
- Patients with a history of abdominal surgery
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 |
|---|---|---|
| HFNO groupAlso: Optiflow100% oxygen supplied in proportion to body weight using the Optiflow THRIVETM system while maintaining jaw thrust. (0-12 kg; 2 L/kg/min, 13-15 kg; 30 L/min, 16-30 kg; 35 L/min, 31-50 kg; 40 L/min) | Device | High-flow nasal oxygenation group (HFNO group) |
| MV groupMask ventilation using the one-hand E-C clamp technique and oropharyngeal airway (fresh gas flow 3 l/min, 100% O2, tidal volume 8-10 ml/kg, respiratory rate 20/min, I:E ratio 1:2, pop-off valve 13 cmH2O). | Device | Facemask ventilation group (MV group) |
Primary outcome
Incidence of gastric insufflation
Time frame: From the start of anesthesia induction to 3 minutes after anesthesia induction
Incidence of gastric insufflation detected by gastric ultrasound (acoustic shadow phenomenon or comet-tail artifact in the antrum) or by epigastric auscultation (typical 'gurgling' or 'whoosh' sound)
5 secondary outcomes
Gastric insufflation detected by ultrasound
Time frame: 3 minutes after anesthesia induction
Gastric insufflation detected by auscultation
Time frame: From the start of anesthesia induction to 3 minutes after anesthesia induction
gastric antrum longitudinal diameter (D1)
Time frame: 3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2)
Time frame: 3 minutes after anesthesia induction
gastric antral cross-sectional area (CSA)
Time frame: 3 minutes after anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HFNO group and MV group in people with Induction of General Anesthesia, run by Ajou University School of Medicine.
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 3 inclusion and 5 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Incidence of gastric insufflation (time frame: From the start of anesthesia induction to 3 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.