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NCT Number: NCT03147469

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

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.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexion

Procedure

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

Extension

Procedure

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

Right rotation

Procedure

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

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: 30 seconds after positioning of head and neck

    The 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 outcomes

  1. Peak inspiratory pressure

    Time frame: 30 seconds after positioning of head and neck

    Peak inspiratory pressure

  2. Expiratory tidal volume

    Time frame: 30 seconds after positioning of head and neck

    Expiratory tidal volume

  3. Ventilation score

    Time frame: 30 seconds after positioning of head and neck

    No leakage with an airway pressure of 15cmH2O; bilateral chest excursion with a peak inspiratory pressure of 20cmH2O; and a square-wave capnogram

  4. Fiberoptic score

    Time frame: 30 seconds after positioning of head and neck

    1, vocal cords not visible; 2, vocal cords plus anterior epiglottis visible; 3, vocal cords plus posterior epiglottis visible; 4, only vocal cords visible

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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