The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are less suitable for airway maintenance under general anesthesia in small infants and that they may even be associated with more frequent complications than with the facemask and endotracheal tube. The pediatric i-gel is a new supraglottic airway device for children. It is made of a soft, gel-like elastomer with a noninflatable cuff. Studies about I-gel in adults have been promising, showing an easy insertion, high airway leak pressures, and low complication rates with few postoperative complaints. The aim of this study is to compare clinical performance of the pediatric i-gel and c-LMA in infants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

NCT01320163

Endotracheal Intubation

COMPLETED NA

The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants

NCT01863316

Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway

UNKNOWN NA

Application of I-gel Laryngeal Mask Airway in Pediatric Patients

NCT03748589

the Efficacy and Performance of the Pediatric I-gel Mask

COMPLETED NA

I-gel Versus Classic-Laryngeal Mask Airway (C-LMA) as a Conduit for Tracheal Intubation Using Ventilating Bougie

NCT02566135

Intubation; Difficult

COMPLETED NA

The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Elderly Patients

NCT02026791

The Elderly Patients Aged Between 65 and 85

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Complication of Anaesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LMA group

Group Type ACTIVE_COMPARATOR

classic-laryngeal mask airway (c-LMA)

Intervention Type DEVICE

Insertion of c-LMA

I-gel group

Group Type EXPERIMENTAL

i-gel™

Intervention Type DEVICE

Insertion of I-gel

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

classic-laryngeal mask airway (c-LMA)

Insertion of c-LMA

Intervention Type DEVICE

i-gel™

Insertion of I-gel

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* infants (0-1 year of age)
* who scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria

* patients with an abnormal airway
* with reactive airway disease
* with gastroesophageal reflux disease
* with chronic respiratory disease
* has a history of an upper respiratory tract infection in the preceding 6-week period

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No