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

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Procedure: Right rotation; Procedure: Extension; Procedure: Flexion

• Registration Number: NCT03147469
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Study Start: 2017-05-17
• Primary Completion: 2017-07-05
• Study Completion: 2017-07-05
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-26
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Right rotation	Right rotation	After positioning the subjects' head to right rotation, the variables will be assessed.
Extension	Extension	After positioning the subjects' neck to extension, the variables will be assessed.
Flexion	Flexion	After positioning the subjects' neck to flexion, the variables will be assessed.

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure	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 Outcome Measures

Name	Time	Method
Peak inspiratory pressure	30 seconds after positioning of head and neck	Peak inspiratory pressure
Ventilation score	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
Fiberoptic score	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
Expiratory tidal volume	30 seconds after positioning of head and neck	Expiratory tidal volume

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of