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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147469
• Other study ID #: H-1704-068-844
• Status: Completed
• Phase: N/A
• First received: May 8, 2017
• Last updated: December 26, 2017
• Start date: May 17, 2017
• Est. completion date: July 5, 2017

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 5, 2017
• Est. primary completion date: July 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Procedure:
• Flexion
After changing the position of head and neck of subjects to flexion, the variables were measured.
• Extension
After changing the position of head and neck of subjects to extension, the variables were measured.
• Right rotation
After changing the position of head and neck of subjects to right flexion, the variables were measured.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Peak inspiratory pressure	Peak inspiratory pressure	30 seconds after positioning of head and neck
Secondary	Expiratory tidal volume	Expiratory tidal volume	30 seconds after positioning of head and neck
Secondary	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
Secondary	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