Pediatric Endotracheal Intubation
Conditions
Keywords
AMBU® AURAGAIN™, intubation in paediatrics, flexible scope guided intubation, success rate of intubation, glottic view, supraglottic airway intubation, efficacy safety
Brief summary
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
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
Interventions
DEVICEIntubation via AMBU® AURAGAIN™
Success rate of paediatric intubation through AMBU® AURAGAIN™
Sponsors
University of Malaya
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time taken to successful intubation via the Ambu® AuraGain™ | Time taken during procedure ( measured in seconds ) | Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken required for removal of Ambu® AuraGain™ post intubation | Time taken during procedure ( measured in seconds ) | Successful removal of device is confirmed by equal air entry heard bilaterally on auscultation and a positive capnograph tracing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time required for insertion of Ambu® AuraGain™ | Time taken during procedure ( measured in seconds ) | Device insertion is limited to two attempts |
| Determine oropharyngeal leak pressure of Ambu® AuraGain™ | Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg ) | Standard oropharyngeal leak test performed |
Countries
Malaysia
Outcome results
None listed