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Completed

NCT Number: NCT05106478

AuraGain Performance in Lateral Position

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.

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Key information

Conditions

Airway Complication of Anesthesia

Age range

2 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hala Abdel-Ghaffar

Asyut, Asyut Governorate, 71515, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AuraGain

Device

Ambu® AuraGain, a relatively novel supraglottic airway device, has been introduced recently. AuraGain has an inflatable cuff and a curved body.

Primary outcomes

  1. Oropharyngeal leak pressure

    Time frame: Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device

    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".

Secondary outcomes

  1. Ventilation score (grade 0, 1, 2 or 3),

    Time frame: Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device

    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.

  2. Fiberoptic glottic view Score

    Time frame: Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.

    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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: AuraGainLMA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2021
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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