Evaluation of the Pediatric Igel Airway in 250 Children

University Hospitals Bristol and Weston NHS Foundation Trust120 enrolled

Overview

Once a child has been anaesthetised and is fully asleep, a special airway tube called a laryngeal mask is often inserted into their mouth to help with their breathing. This tube is removed just before the child wakes up. A new type of airway tube, called an i-gel airway, has been developed for children, which is hoped will be easier to insert, safer once in position, and will be less likely to cause a sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has been available for adults since 2007, and early trials have shown very encouraging results.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Anesthesia Child Infant

Eligibility

Sex: ALLMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All children weighing 5 -30kg * Classified by the American Society of Anesthesiology (ASA) as grade 1-2, * Scheduled for elective surgery under general anaesthesia, in whom a LMA or PLMA would otherwise be used for airway maintenance and in whom neuromuscular blocking drugs will not be used. Exclusion Criteria: * Inability of patient or parents to understand the study or consent process * Neck pathology * Previous or anticipated airway problems * Pathology of airway, respiratory tract, upper gastrointestinal tract * Increased risk of regurgitation or aspiration * Weight \>30kg or \<5 kg * ASA 3 and above, * Emergency surgery

Outcomes

Primary Outcomes

Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?

Time frame: during anaesthesia

Secondary Outcomes

Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae

Time frame: during anaesthesia and up to 24 hours postoperatively