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

Not Applicable

Not yet recruiting

• Conditions: Induction of General Anesthesia
• Interventions: Device: HFNO group; Device: MV group

• Registration Number: NCT06204653
• Lead Sponsor: Ajou University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study Start: 2024-01-02
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal oxygenation group (HFNO group)	HFNO group	-
Facemask ventilation group (MV group)	MV group	-

Primary Outcome Measures

Name	Time	Method
Incidence of gastric insufflation	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)

Secondary Outcome Measures

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