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

NCT03147469 | Completed DMC

• 1 other identifier: H-1704-068-844
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Peak inspiratory pressure

  30 seconds after positioning of head and neck

• Expiratory tidal volume

  30 seconds after positioning of head and neck

• Ventilation score

  30 seconds after positioning of head and neck

• Fiberoptic score

  30 seconds after positioning of head and neck

Study Arms (4)

Neutral

NO INTERVENTION

After insertion of Ambu AuraGain™, the variables will be assessed at each positions including neutral, flexion, extension, right rotation under random order.

Flexion

EXPERIMENTAL

After positioning the subjects' neck to flexion, the variables will be assessed.

Procedure: Flexion

Extension

EXPERIMENTAL

After positioning the subjects' neck to extension, the variables will be assessed.

Procedure: Extension

Right rotation

EXPERIMENTAL

After positioning the subjects' head to right rotation, the variables will be assessed.

Procedure: Right rotation

Interventions

Flexion PROCEDURE

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

Flexion

Extension PROCEDURE

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

Extension

Right rotation PROCEDURE

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

Right rotation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: May 17, 2017
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

KR (1)