A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg

Study Overview
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Brief Summary
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The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing <10kg.

Detailed Description
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This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.

Official Title
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A Randomized Comparison of LMA Supreme and LMA Proseal in Infants Below 10kg

Conditions
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Laryngeal Mask Airway

Intervention / Treatment
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* Device: LMA Supreme
* Device: LMA Proseal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight of < 10kg ASA (American Society of Anesthesiologists) I-II Infants undergoing elective surgery under general anaesthesia using supraglottic airway device. Informed consent obtained from parents. Exclusion Criteria: ASA III-IV and emergency surgery Neonates and ex-premature babies with post conceptual age <55 weeks. Infants with history of difficult airway. Infants with features of difficult intubation. Active upper respiratory tract infection Infants with pulmonary disease Infants with history of gastroesophageal reflux disease Infants with risks of regurgitation and aspiration.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMA Supreme<br>1 arm will receive LMA supreme for airway management | Device: LMA Supreme<br>* The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.<br>|
| Active Comparator: LMA Proseal<br>1 arm will receive LMA Proseal for airway management | Device: LMA Proseal<br>* The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | The measurement of oropharyngeal airway pressure when airway leak occurred | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate | The number of attempts for successful placement of the supraglottic airway is recorded. | intraoperative | 
| Fibreoptic glottis view | Fibreoptic glottis view will be recorded according to a grading system | intraoperative | 
| Intraoperative complications | Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded | intraoperative | 
| Time to insertion | Time from picking up the supraglottic airway device to the first detection of capnography square wave | intraoperative |