CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 413 enrolled
Drug / intervention
laryngeal mask airwaydevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03748589
NCT03748589N/ACompleted

Application of I-gel Laryngeal Mask Airway in Infants and Children Undergoing Surgical Procedures

Xian Children's Hospital·interventional·Posted Nov 21, 2018·Updated Aug 31, 2020

In Brief

A clinical study evaluating laryngeal mask airway for the Efficacy and Performance of the Pediatric I-gel Mask. Completed, enrolled 413 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 21, 2018
Enrollment StartDec 12, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.6 years ago

Interventions

laryngeal mask airwaydevice

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.