Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

University of Malaya

Status: Completed

Conditions: Pediatric Endotracheal Intubation

Treatments: Device: Intubation via AMBU® AURAGAIN™

Study type: Interventional

Funder types: Other

Identifiers

NCT03955094

Auragain study

Details and patient eligibility

About

This study will be conducted as a prospective observational study

This study will be done in any of the operating theatres of University Malaya Medical Centre

This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation

Ambu Aura Gain will be used as a conduit for intubation

Full description

All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded

Enrollment: 16 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Paediatric patients aged 3 - 12 years old
• American Society of Anaesthesiologist (ASA) 1-2 patients
• Patients must require standard endotracheal intubation for the procedure posted

Exclusion criteria

• Documented history of difficult airway in previous general anaesthesia
• Clinical features of difficult airway on physical examination
• Syndromic patients, facial deformities, dental deformities, patients with facial trauma
• Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
• Patients with existing pulmonary diseases or any risk of bronchospasm
• Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration
• Any other contraindication for device placement
• Operations requiring specialised endotracheal tubes
• Emergency operations or unanticipated difficult airway cases
• Refusal of parental informed consent

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

AMBU® AURAGAIN™ device

Experimental group

Description:

Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics

Treatment:

Device: Intubation via AMBU® AURAGAIN™