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

King Saud University

Status: Completed

Conditions: Laryngeal Masks

Treatments: Device: I-Gel LMA; Device: Ambu LMA

Study type: Interventional

Funder types: Other

Identifiers

NCT02938039

E14-1153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 1 day to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Ambu LMA

Active Comparator group

Description:

Ambu Laryngeal Mask Airway device of different sizes for age

Treatment:

Device: Ambu LMA

I-Gel LMA

Active Comparator group

Description:

I-Gel Laryngeal Mask Airway device of different sizes for age

Treatment:

Device: I-Gel LMA