Clinical trial NCT05106478: AuraGain Performance in Lateral Position
Official title: A Randomized Comparison of Pediatric® AuraGain in Supine, Moderate Lateral, and Extreme Lateral Positions in Terms of Clinical Performance and Fiber Optic Glottic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - children scheduled for elective outpatient surgery in which airway management with a® AuraGain would be appropriate.

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: Intraoperative from 1 minute after insertion of the device as a baseline to 60 minutes after insertion of the device
Secondary outcomes:
measure: Ventilation score (grade 0, 1, 2 or 3),
timeFrame: Intraoperative from 1 minute after insertion of the device as baseline to 60 minutes after insertion of the device
measure: Fiberoptic glottic view Score
timeFrame: Intraoperative from 1 minute after insertion of the device to 60 minutes after insertion of the device.
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Hala Abdel-Ghaffar
state: Asyut Governorate
Study officials:
affiliation: Assiut University
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: