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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMBU® AURAGAIN™ device | Experimental | Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intubation via AMBU® AURAGAIN™ | Device | Success rate of paediatric intubation through AMBU® AURAGAIN™ |
|
| 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 ) |
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for insertion of Ambu® AuraGain™ | Device insertion is limited to two attempts | Time taken during procedure ( measured in seconds ) |
| Determine oropharyngeal leak pressure of Ambu® AuraGain™ |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismiarti S Ina, MAnaes(UM) | University of Malaya | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya | Kuala Lumpur | 59100 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21973052 | Background | Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x. | |
| 26417722 | Background | Pandey RK, Subramanium RK, Darlong V, Lekha C, Garg R, Punj J, Rewari V, Bajpai M. Evaluation of glottic view through Air-Q Intubating Laryngeal Airway in the supine and lateral position and assessing it as a conduit for blind endotracheal intubation in children in the supine position. Paediatr Anaesth. 2015 Dec;25(12):1241-7. doi: 10.1111/pan.12746. Epub 2015 Sep 29. |
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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
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Standard oropharyngeal leak test performed
| Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg ) |
| 21081777 | Background | Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16. |
| 22971118 | Background | Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13. |
| 25537736 | Background | Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24. |
| 25422603 | Background | Girgis KK, Youssef MM, ElZayyat NS. Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients. Saudi J Anaesth. 2014 Oct;8(4):470-6. doi: 10.4103/1658-354X.140841. |