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

Not Applicable

Completed

• Conditions: Laryngeal Masks
• Interventions: Device: Ambu LMA; Device: I-Gel LMA

• Registration Number: NCT02938039
• Lead Sponsor: King Saud University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu LMA	Ambu LMA	Ambu Laryngeal Mask Airway device of different sizes for age
I-Gel LMA	I-Gel LMA	I-Gel Laryngeal Mask Airway device of different sizes for age

Primary Outcome Measures

Name	Time	Method
Airway Leak Pressure	17 months	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

Secondary Outcome Measures

Name	Time	Method
Success at first attempt	18 months	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)
Oxygen Desaturation less than 90%	18 months	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
Gastric Insufflation	18 months	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
Manipulation of the Device	18 months	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
Effective airway time	18 months	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
Ease of insertion	18 months	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)