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.

Study Overview

• Status: Completed
• Conditions: General Anesthesia
• Intervention / Treatment: Procedure: Flexion; Procedure: Extension; Procedure: Right rotation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Neutral; After insertion of Ambu AuraGain™, the variables will be assessed at each positions including neutral, flexion, extension, right rotation under random order.
EXPERIMENTAL: Flexion; After positioning the subjects' neck to flexion, the variables will be assessed.	Procedure: Flexion; After changing the position of head and neck of subjects to flexion, the variables were measured.
EXPERIMENTAL: Extension; After positioning the subjects' neck to extension, the variables will be assessed.	Procedure: Extension; After changing the position of head and neck of subjects to extension, the variables were measured.
EXPERIMENTAL: Right rotation; After positioning the subjects' head to right rotation, the variables will be assessed.	Procedure: Right rotation; After changing the position of head and neck of subjects to right flexion, the variables were measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure	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.	30 seconds after positioning of head and neck

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak inspiratory pressure	Peak inspiratory pressure	30 seconds after positioning of head and neck
Expiratory tidal volume	Expiratory tidal volume	30 seconds after positioning of head and neck
Ventilation score	No leakage with an airway pressure of 15cmH2O; bilateral chest excursion with a peak inspiratory pressure of 20cmH2O; and a square-wave capnogram	30 seconds after positioning of head and neck
Fiberoptic score	1, vocal cords not visible; 2, vocal cords plus anterior epiglottis visible; 3, vocal cords plus posterior epiglottis visible; 4, only vocal cords visible	30 seconds after positioning of head and neck

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2017
• Primary Completion (ACTUAL): July 5, 2017
• Study Completion (ACTUAL): July 5, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: H-1704-068-844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No