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Effect of High-flow Nasal Oxygenation on Gastric Insufflation in Children

The Effect of High-flow Nasal Oxygenation Versus Mask Ventilation on Gastric Insufflation in Children: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06204653
Enrollment
70
Registered
2024-01-12
Start date
2024-01-02
Completion date
2024-12-31
Last updated
2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of General Anesthesia

Keywords

High flow nasal oxygenation, Facemask ventilation, Gastric insufflation

Brief 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.

Interventions

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)

DEVICEMV group

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).

Sponsors

Ajou University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric patients aged 1 to 6 years * American Society of Anesthesiologists physical classification 1 or 2 * Scheduled for general anesthesia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of gastric insufflationFrom the start of anesthesia induction to 3 minutes after anesthesia inductionIncidence 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)

Secondary

MeasureTime frameDescription
Gastric insufflation detected by ultrasound3 minutes after anesthesia inductionPresence of acoustic shadow phenomenon or comet-tail artifact detected by ultrasound
Gastric insufflation detected by auscultationFrom the start of anesthesia induction to 3 minutes after anesthesia inductionPresence of 'gurgling' or 'whoosh' sound detected by auscultation of the epigastrium.
gastric antrum longitudinal diameter (D1)3 minutes after anesthesia inductiongastric antrum longitudinal diameter (D1) measured by ultrasound
gastric antrum anteroposterior diameter (D2)3 minutes after anesthesia inductiongastric antrum anteroposterior diameter (D2) measured by ultrasound
gastric antral cross-sectional area (CSA)3 minutes after anesthesia inductiongastric antral cross-sectional area (CSA) measured by ultrasound (CSA = (D1 Ⅹ D2 Ⅹ π)/4)

Other

MeasureTime frameDescription
MAPEvery 1 minute during intervention (baseline, 1, 2, 3 min after induction)Mean arterial pressure
Lowest SpO2From the start of anesthesia induction to completion of tracheal intubationLowest peripheral oxygen saturation during intervention
HREvery 1 minute during intervention (baseline, 1, 2, 3 min after induction)Heart rate
SpO2Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)Peripheral oxygen saturation
TVEvery 1 minute during intervention (1, 2, 3 min after induction)Tidal volume in MV group
PIPEvery 1 minute during intervention (1, 2, 3 min after induction)Peak airway pressure in MV group
ETCO2Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubationEnd tidal CO2 in MV group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026