NCT02938039

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 1 Day – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Masks

Interventions

Type	Name	Description
DEVICE	Ambu LMA	Ambu Laryngeal Mask Airways
DEVICE	I-Gel LMA	I-Gel Laryngeal Mask Airways

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2016-10-19
• Last updated: 2016-10-19