Evaluation of the Pediatric Igel Airway in 250 Children

This study has been terminated.
(Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited)
Royal United Hospital Bath NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
First received: August 31, 2009
Last updated: December 14, 2011
Last verified: December 2011

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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants

Further study details as provided by University Hospitals Bristol NHS Trust:

Primary Outcome Measures:
  • Does the i−gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? [ Time Frame: during anaesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
between 10 and 30 kgs
between 5 - 10 kg


Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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


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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969189

United Kingdom
UH Bristol NHS Foundation Trust
Bristol, Avon, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Trust
Royal United Hospital Bath NHS Trust
Principal Investigator: Michelle White, MB ChB UH Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT00969189     History of Changes
Other Study ID Numbers: CH/2008/2808, NRES ID: 08/H0101/198
Study First Received: August 31, 2009
Last Updated: December 14, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals Bristol NHS Trust:
laryngeal mask

ClinicalTrials.gov processed this record on April 22, 2014