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The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children

The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03127683
Enrollment
40
Registered
2017-04-25
Start date
2017-05-15
Completion date
2017-11-30
Last updated
2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Brief summary

The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated. This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway. An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Interventions

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

OTHERFlexion

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position

DEVICEAmbu AuraGain TM

Single Use Laryngeal Mask Sterile

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes

Inclusion criteria

* Children \< 7 years old who scheduled for general anesthesia using supraglottic airway

Exclusion criteria

* Children who require tracheal intubation * Emergency operation without NPO * History of C-spine surgery or disease * History of Esophageal disease or surgery

Design outcomes

Primary

MeasureTime frameDescription
Oropharyngeal leak pressure30 seconds after positioning of head and neckThe airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min

Secondary

MeasureTime frameDescription
Peak inspiratory pressure30 seconds after positioning of head and neckpeak airway pressure
Tidal volume30 seconds after positioning of head and neckExpiratory tidal volume
Fiberopic bronchoscopic view30 seconds after positioning of head and neck1\. No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only visible glottis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026