Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

Conditions
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Pediatric Endotracheal Intubation

Intervention / Treatment
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* Device: Intubation via AMBU® AURAGAIN™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMBU® AURAGAIN™ device<br>Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics | Device: Intubation via AMBU® AURAGAIN™<br>* Success rate of paediatric intubation through AMBU® AURAGAIN™<br>* Other names: Supraglottic device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 taken during procedure ( measured in seconds ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 taken during procedure ( measured in seconds ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMBU® AURAGAIN™, intubation in paediatrics, flexible scope guided intubation, success rate of intubation, glottic view, supraglottic airway intubation, efficacy safety