NCT06204653

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

December 26, 2023

Last Update Submit

January 11, 2024

Conditions

Induction of General Anesthesia

Keywords

High flow nasal oxygenationFacemask ventilationGastric insufflation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Gastric insufflation detected by ultrasound

    3 minutes after anesthesia induction

  • Gastric insufflation detected by auscultation

    From the start of anesthesia induction to 3 minutes after anesthesia induction

  • gastric antrum longitudinal diameter (D1)

    3 minutes after anesthesia induction

  • gastric antrum anteroposterior diameter (D2)

    3 minutes after anesthesia induction

  • gastric antral cross-sectional area (CSA)

    3 minutes after anesthesia induction

Other Outcomes (7)

  • MAP

    Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)

  • HR

    Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)

  • SpO2

    Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)

  • +4 more other outcomes

Study Arms (2)

High-flow nasal oxygenation group (HFNO group)

EXPERIMENTAL
Device: HFNO group

Facemask ventilation group (MV group)

ACTIVE COMPARATOR
Device: MV group

Interventions

HFNO groupDEVICE

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
High-flow nasal oxygenation group (HFNO group)
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).

Facemask ventilation group (MV group)

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 12, 2024

Study Start

January 2, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01