Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

University of Malaya16 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pediatric Endotracheal Intubation

Interventions

Intubation via AMBU® AURAGAIN™DEVICE

Success rate of paediatric intubation through AMBU® AURAGAIN™

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Malaya

Kuala Lumpur, Malaysia

Outcomes

Primary Outcomes

Time taken to successful intubation via the Ambu® AuraGain™

Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing

Time frame: Time taken during procedure ( measured in seconds )

Secondary Outcomes

Time taken required for removal of Ambu® AuraGain™ post intubation

Successful removal of device is confirmed by equal air entry heard bilaterally on auscultation and a positive capnograph tracing

Time frame: Time taken during procedure ( measured in seconds )

Data from ClinicalTrials.gov

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