Evaluation of the Pediatric Igel Airway in 250 Children
|ClinicalTrials.gov Identifier: NCT00969189|
Recruitment Status : Terminated (Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited)
First Posted : September 1, 2009
Last Update Posted : December 15, 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.
|Condition or disease|
|Anesthesia Child Infant|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants|
|Study Start Date :||August 2009|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
between 10 and 30 kgs
between 5 - 10 kg
- Does the i−gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? [ Time Frame: during anaesthesia ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969189
|UH Bristol NHS Foundation Trust|
|Bristol, Avon, United Kingdom, BS2 8BJ|
|Principal Investigator:||Michelle White, MB ChB||UH Bristol NHS Foundation Trust|