Study Stopped
Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited
Evaluation of the Pediatric Igel Airway in 250 Children
A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
2 other identifiers
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedDecember 15, 2011
December 1, 2011
1.6 years
August 31, 2009
December 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
during anaesthesia
Secondary Outcomes (1)
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
Study Arms (2)
Children
between 10 and 30 kgs
Infants
between 5 - 10 kg
Eligibility Criteria
children between 10 - 30 kgs infants between 5-10 kgs
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UH Bristol NHS Foundation Trust
Bristol, Avon, BS2 8BJ, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle White, MB ChB
UH Bristol NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant in Paediatric Anaesthesia and Critical Care
Study Record Dates
First Submitted
August 31, 2009
First Posted
September 1, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
December 15, 2011
Record last verified: 2011-12