An interventional study of HFNO group and MV group in Induction of General Anesthesia, sponsored by Ajou University School of Medicine. Not yet recruiting. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Ajou University School of Medicine · Not applicable, Interventional, and Prevention
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.
Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: HFNO group
Device: MV group
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)
Also known as: Optiflow
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).
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)
Time frame: From the start of anesthesia induction to 3 minutes after anesthesia induction
Gastric insufflation detected by ultrasound
Presence of acoustic shadow phenomenon or comet-tail artifact detected by ultrasound
Time frame: 3 minutes after anesthesia induction
Gastric insufflation detected by auscultation
Presence of 'gurgling' or 'whoosh' sound detected by auscultation of the epigastrium.
Time frame: 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
Time frame: 3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2)
gastric antrum anteroposterior diameter (D2) measured by ultrasound
Time frame: 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)
Time frame: 3 minutes after anesthesia induction
MAP
Mean arterial pressure
Time frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
HR
Heart rate
Time frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
SpO2
Peripheral oxygen saturation
Time frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
TV
Tidal volume in MV group
Time frame: Every 1 minute during intervention (1, 2, 3 min after induction)
PIP
Peak airway pressure in MV group
Time frame: Every 1 minute during intervention (1, 2, 3 min after induction)
ETCO2
End tidal CO2 in MV group
Time frame: Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubation
Lowest SpO2
Lowest peripheral oxygen saturation during intervention
Time frame: From the start of anesthesia induction to completion of tracheal intubation
No study locations are listed for this record.
Start is estimated for Jan 2024; primary completion for Dec 2024, 11 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Ajou University School of Medicine →