Evaluation of the Pediatric Igel Airway in 250 Children

A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants

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 Overview

• Status: Terminated
• Conditions: Child; Anesthesia; Infant

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United Kingdom
  • Avon
    • Bristol, Avon, United Kingdom, BS2 8BJ
      • UH Bristol NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children between 10 - 30 kgs infants between 5-10 kgs

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children; between 10 and 30 kgs
Infants; between 5 - 10 kg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
• Collaborators: Royal United Hospital Bath NHS Trust
• Investigators: Principal Investigator: Michelle White, MB ChB, UH Bristol NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (Estimate): September 1, 2009

Study Record Updates

• Last Update Posted (Estimate): December 15, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: anesthesia; child; infant; laryngeal mask
• Other Study ID Numbers: CH/2008/2808; NRES ID: 08/H0101/198