MedTrace Logo

Application of I-gel Laryngeal Mask Airway in Pediatric Patients

NCT03748589 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2020-08-31

No results posted yet for this study

Summary

Background The laryngeal mask airway (LMA) is a supraglottic airway device ,which is commonly used to manage children's airways, because it is typically easy to use and can avoid problems specific to tracheal intubation. Since the LMA was introduced into clinical practice in 1988 , various types of LMAs have been developed, the safety and efficacy of which have been established in both adults and children.The paediatric i-gel is a relatively new and disposable supraglottic airway device for children, which is made of a soft gel-like elastomer with a non-inflatable cuff and a channel for gastric catheter placement . It does not require cuff inflation ,reducing the complications associated with compression trauma and high cuff pressure . Medical-grade thermoplastic elastomer creates a more intimate interface for interacting with supraglottic tissue. The usage of i-gel mask is more common in adults ,though a large scale study focusing on children is lacking.

Objectives:

To evaluate the efficacy and performance of the pediatric i-gel mask

Methods:

From November 2018 to March 2019, subjects are selected from patients who undergo elective surgery at Xi'an Children's Hospital, within the age of 0 to 108 months old, with an American Society of Anesthesiologists physical status I or II .They were assigned into four groups according to their weight. Four groups are : 2-5 kg (group 1#), 5.1-12.0 kg (group 1.5#), 10-25kg (group 2#) 25-35kg(group 2.5#). The primary outcome is the clinical performance of the airways: the rate of insertion at first attempt,the ease of insertion,the insertion time,the oropharyngeal leak pressure(OLP),the fibreoptic view and the ease of gastric tube insertion. The secondary outcome is the frequency of other perioperative complications as listed in the detail information section.

Conditions

  • the Efficacy and Performance of the Pediatric I-gel Mask

Interventions

DEVICE

laryngeal mask airway

i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.

Sponsors & Collaborators

  • Xian Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • fang li yang, doctor · Xian Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
108 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03748589 on ClinicalTrials.gov