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)
Sponsor:
Collaborator:
Royal United Hospital Bath NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT00969189
First received: August 31, 2009
Last updated: December 14, 2011
Last verified: December 2011

August 31, 2009
December 14, 2011
August 2009
March 2011   (final data collection date for primary outcome measure)
Does the i−gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? [ Time Frame: during anaesthesia ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00969189 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Anesthesia
  • Child
  • Infant
Not Provided
  • Children
    between 10 and 30 kgs
  • Infants
    between 5 - 10 kg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
up to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00969189
CH/2008/2808, NRES ID: 08/H0101/198
No
Michelle White, University Hospitals Bristol NHS Trust
University Hospitals Bristol NHS Trust
Royal United Hospital Bath NHS Trust
Principal Investigator: Michelle White, MB ChB UH Bristol NHS Foundation Trust
University Hospitals Bristol NHS Trust
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP