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

NCT ID: NCT06204653

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Induction of General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High-flow nasal oxygenation group (HFNO group)

Group Type EXPERIMENTAL

HFNO group

Intervention Type DEVICE

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)

Facemask ventilation group (MV group)

Group Type ACTIVE_COMPARATOR

MV group

Intervention Type DEVICE

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).

Interventions

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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)

Intervention Type 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).

Intervention Type DEVICE

Other Intervention Names

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Optiflow

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jong Yeop Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AJOUIRB-IV-2023-584

Identifier Type: -

Identifier Source: org_study_id

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