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The Influence of Head and Neck Position on Performance of Ambu AuraGain™

The Influence of Head and Neck Position on Performance of Ambu AuraGain™

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03147469
Enrollment
40
Registered
2017-05-10
Start date
2017-05-17
Completion date
2017-07-05
Last updated
2017-12-28

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. 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. Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.

Interventions

PROCEDUREFlexion

After changing the position of head and neck of subjects to flexion, the variables were measured.

PROCEDUREExtension

After changing the position of head and neck of subjects to extension, the variables were measured.

PROCEDURERight rotation

After changing the position of head and neck of subjects to right flexion, the variables were measured.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

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. Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults who were to undergo elective surgery under general anaesthesia using supraglottic airway device

Exclusion criteria

* Patients who had risk factor for difficult intubation * BMI \> 30kg/m2 * Emergency operation without NPO * History of cervical spine surgery or disease * History of esophageal operation or gastroesophageal reflux disease

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 inspiratory pressure
Expiratory tidal volume30 seconds after positioning of head and neckExpiratory tidal volume
Ventilation score30 seconds after positioning of head and neckNo leakage with an airway pressure of 15cmH2O; bilateral chest excursion with a peak inspiratory pressure of 20cmH2O; and a square-wave capnogram
Fiberoptic score30 seconds after positioning of head and neck1, vocal cords not visible; 2, vocal cords plus anterior epiglottis visible; 3, vocal cords plus posterior epiglottis visible; 4, only vocal cords visible

Countries

South Korea

Outcome results

None listed

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