AuraGain Performance in Lateral Position

NCT ID: NCT05106478

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-12-29

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).

Conditions

Airway Complication of Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

AuraGain

Intervention Type: DEVICE

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.

AuraGain

Intervention Type: DEVICE

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

Interventions

AuraGain

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Hala Abdel-Ghaffar

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

17101416

Identifier Type: -

Identifier Source: org_study_id