Evaluation of the Pediatric Igel Airway in 250 Children

University Hospitals Bristol and Weston NHS Foundation Trust

Status: Terminated

Conditions: Child; Infant; Anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT00969189

NRES ID: 08/H0101/198

CH/2008/2808

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Children

Description:

between 10 and 30 kgs

Infants

Description:

between 5 - 10 kg