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

NCT ID: NCT02938039

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-10-31

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.

Conditions

Laryngeal Masks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ambu LMA

Ambu Laryngeal Mask Airway device of different sizes for age

Group Type: ACTIVE_COMPARATOR

Ambu LMA

Intervention Type: DEVICE

Ambu Laryngeal Mask Airways

I-Gel LMA

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

Group Type: ACTIVE_COMPARATOR

I-Gel LMA

Intervention Type: DEVICE

I-Gel Laryngeal Mask Airways

Interventions

Ambu LMA

Ambu Laryngeal Mask Airways

Intervention Type: DEVICE

I-Gel LMA

I-Gel Laryngeal Mask Airways

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Dr Abdulrahman Alzahem

Associate Professor and Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdulrahman M Alzahem, MD

Role: PRINCIPAL_INVESTIGATOR

King Saud University

Other Identifiers

E14-1153

Identifier Type: -

Identifier Source: org_study_id