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Evaluation of the Pediatric Igel Airway in 250 Children

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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Anesthesia Child Infant

Study Design

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Does the i−gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? [ Time Frame: during anaesthesia ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children between 10 - 30 kgs infants between 5-10 kgs
Criteria

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

Information from the National Library of Medicine

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


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

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
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

Keywords provided by Michelle White, University Hospitals Bristol NHS Trust:
anesthesia
child
infant
laryngeal mask