Evaluation of the Pediatric Igel Airway in 250 Children

Terminated

• Conditions: Anesthesia; Child; Infant

• Registration Number: NCT00969189
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-14
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?	during anaesthesia

Secondary Outcome Measures

Name	Time	Method
Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae	during anaesthesia and up to 24 hours postoperatively

Trial Locations

Locations (1)

UH Bristol NHS Foundation Trust; 🇬🇧 Bristol, Avon, United Kingdom