AuraGain Performance in Lateral Position (AuraGainLMA)

A Randomized Comparison of Pediatric® AuraGain in Supine, Moderate Lateral, and Extreme Lateral Positions in Terms of Clinical Performance and Fiber Optic Glottic

To compare the clinical performance of AuraGain including insertion time and success rate at first attempt, fiberoptic bronchoscopic view, oropharyngeal leak pressure, the degree of ease of gastric tube insertion, and peri-operative adverse effects in young children in supine, moderate lateral and extreme lateral position.

Study Overview

• Status: Completed
• Conditions: Airway Complication of Anesthesia
• Intervention / Treatment: Device: AuraGain

Detailed Description

Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body. In addition, because the airway tube of AuraGain is wide, it can be used as a conduit for tracheal intubation. However, only a limited number of studies have been conducted on the performance of AuraGain in pediatric patients.

Changes in the position of the head and neck alter the shape of the pharynx leading to changes in the oropharyngeal leak pressure and the quality of ventilation through the LMA in both the adult and pediatric population. Having a large occiput and a relatively cephalically placed glottis, the ventilation in children is more compromised due to poor alignment of the pharyngeal-laryngeal axes during flexion of the head and neck. The hanging epiglottis covers the laryngeal inlet during flexion and the cuff of the LMA compresses the narrow laryngeal inlet both decreasing the delivered tidal volume. Different changes occur during extension and lateral rotation

Although the clinical performance of the AuraGain would be expected to be high, or at least non-inferior, to that of the widely used currently available SGAs, clinical trials are required to verify its performance in head and neck positions other than the neutral position (i.e flexion, extension and lateral rotation).

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

• Study Contact: Name: Hala S Abdel-Ghaffar, MD; Phone Number: +20 01003812011; Email: hallasaad@yahoo.com
• Study Contact Backup: Name: Mohamed S Abdelmonaem, MB BCH; Phone Number: +20 01066789914

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71515
      • Hala Abdel-Ghaffar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 9 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

- children scheduled for elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

Description

Inclusion Criteria:

• Weight: 15-30 kg.
• Age: 2-9 years.
• Sex: both males and females.
• ASA physical status: 1-3.
• Operation: elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

Exclusion Criteria:

• Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
• Potentially difficult airway.
• Patients with history of neck, respiratory, or digestive tract pathology.
• Patients with gastroesophageal reflux, gastrointestinal stenosis, or stricture.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate lateral Group; Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in moderate lateral position.	Device: AuraGain; Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.
Extreme lateral Group; Patients will be anesthetized using ® AuraGain airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air and operation will undergo while patient's neck in extreme lateral position.	Device: AuraGain; Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak pressure	Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak Pressure".	Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation score (grade 0, 1, 2 or 3),	the ventilation score which is scored from 0 to 3 based on three criteria: no leakage with an airway pressure of 15 cm H2O, bilateral chest excursions with a peak inspiratory pressure of 20 cm of H2O, and a square wave capnogram, with each item scoring 0 or 1 point . Thus, if all three criteria are satisfied, the ventilation score is 3.	Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device
Fiberoptic glottic view Score	The fiberoptic images will be graded with a score from 1 to 5, which has been defined and proposed previously (20, 21); (grade 1-only larynx seen; grade 2-larynx and epiglottis posterior surface seen; grade 3-larynx and epiglottis tip of anterior surface seen, <50%visual obstruction of epiglottis to larynx; grade 4-epiglottis down folded and its anterior surface seen, >50%visual obstruction of epiglottis to larynx; and grade 5-epiglottis down folded and larynx cannot be seen directly). The images will be taken in the neutral position and in mid and extreme laterally rotated neck positions.	Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 17101416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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