I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures

Study Overview
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Brief Summary
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This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis. This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.

Detailed Description
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Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation. There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.

Official Title
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I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial

Conditions
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Laryngeal Masks

Intervention / Treatment
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* Device: Ambu LMA
* Device: I-Gel LMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgical procedures No muscle relaxant agents No other comorbidities Exclusion Criteria: Emergency surgical procedures Full stomach Subjects with upper respiratory tract infection Failed caudal block

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambu LMA<br>Ambu Laryngeal Mask Airway device of different sizes for age | Device: Ambu LMA<br>* Ambu Laryngeal Mask Airways<br>|
| Active Comparator: I-Gel LMA<br>I-Gel Laryngeal Mask Airway device of different sizes for age | Device: I-Gel LMA<br>* I-Gel Laryngeal Mask Airways<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway Leak Pressure | It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely | 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective airway time | It will be measured in seconds unit , and The time for successful insertion will be measured from the moment the facemask will be removed until attainment of first capnography upstroke after insertion | 18 months | 
| Ease of insertion | The ease of placement of LMA will be assessed using a subjective scale of 1-4 (1 = no resistance and no maneuvers, 2 = mild resistance and one maneuver, 3 = moderate resistance and more than one maneuver, 4 = inability to place the device) | 18 months | 
| Success at first attempt | The insertion will be labelled as a 'failure' if the device could not be successfully placed within two attempts or lacked a square-wave capnograph tracing, or if there was airway obstruction (e.g. oxygen desaturation < 90%, abnormal thoraco-abdominal movements, or obstructive noises or no rise of chest at all), inadequate ventilation (an inability to deliver a minimum of 7 ml.kg-1 tidal volumes, or an audible leak) | 18 months | 
| Oxygen Desaturation less than 90% | It is a Yes or No outcome measure and it will be measured using the oxygen saturation monitor placed on finger and the reading will be detected on the capnography | 18 months | 
| Gastric Insufflation | It is a Yes or No outcome measure and auscultation with a stethoscope will be performed over the epigastrium during leak pressure testing to detect the occurrence of gastric insufflation | 18 months | 
| Manipulation of the Device | the number and type of airway manipulations (gentle advancement, withdrawal of device without removal, jaw thrust, or neck extension) required to maintain airway patency during the case will be recorded | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laryngeal airways, infants, neonates, children, anesthetized