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

January 11, 2024 updated by: Jong Yeop Kim, Ajou University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of gastric insufflation
Time Frame: 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)
From the start of anesthesia induction to 3 minutes after anesthesia induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastric insufflation detected by ultrasound
Time Frame: 3 minutes after anesthesia induction
Presence of acoustic shadow phenomenon or comet-tail artifact detected by ultrasound
3 minutes after anesthesia induction
Gastric insufflation detected by auscultation
Time Frame: From the start of anesthesia induction to 3 minutes after anesthesia induction
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)
Time Frame: 3 minutes after anesthesia induction
gastric antrum longitudinal diameter (D1) measured by ultrasound
3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2)
Time Frame: 3 minutes after anesthesia induction
gastric antrum anteroposterior diameter (D2) measured by ultrasound
3 minutes after anesthesia induction
gastric antral cross-sectional area (CSA)
Time Frame: 3 minutes after anesthesia induction
gastric antral cross-sectional area (CSA) measured by ultrasound (CSA = (D1 Ⅹ D2 Ⅹ π)/4)
3 minutes after anesthesia induction

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MAP
Time Frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
Mean arterial pressure
Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
HR
Time Frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
Heart rate
Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
SpO2
Time Frame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
Peripheral oxygen saturation
Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
TV
Time Frame: Every 1 minute during intervention (1, 2, 3 min after induction)
Tidal volume in MV group
Every 1 minute during intervention (1, 2, 3 min after induction)
PIP
Time Frame: Every 1 minute during intervention (1, 2, 3 min after induction)
Peak airway pressure in MV group
Every 1 minute during intervention (1, 2, 3 min after induction)
ETCO2
Time Frame: Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubation
End tidal CO2 in MV group
Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubation
Lowest SpO2
Time Frame: From the start of anesthesia induction to completion of tracheal intubation
Lowest peripheral oxygen saturation during intervention
From the start of anesthesia induction to completion of tracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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