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

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 Overview

• Status: Not yet recruiting
• Conditions: Induction of General Anesthesia
• Intervention / Treatment: Device: HFNO group; Device: MV group

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flow nasal oxygenation group (HFNO group)	Device: HFNO 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); Other Names: Optiflow
Active Comparator: Facemask ventilation group (MV group)	Device: MV 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From the start of anesthesia induction to 3 minutes after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric insufflation detected by ultrasound	Presence of acoustic shadow phenomenon or comet-tail artifact detected by ultrasound	3 minutes after anesthesia induction
Gastric insufflation detected by auscultation	Presence of 'gurgling' or 'whoosh' sound detected by auscultation of the epigastrium.	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	3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2)	gastric antrum anteroposterior diameter (D2) measured by ultrasound	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)	3 minutes after anesthesia induction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP	Mean arterial pressure	Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
HR	Heart rate	Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
SpO2	Peripheral oxygen saturation	Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
TV	Tidal volume in MV group	Every 1 minute during intervention (1, 2, 3 min after induction)
PIP	Peak airway pressure in MV group	Every 1 minute during intervention (1, 2, 3 min after induction)
ETCO2	End tidal CO2 in MV group	Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubation
Lowest SpO2	Lowest peripheral oxygen saturation during intervention	From the start of anesthesia induction to completion of tracheal intubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 2, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: High flow nasal oxygenation; Gastric insufflation; Facemask ventilation
• Other Study ID Numbers: AJOUIRB-IV-2023-584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No