Evaluation of the Pediatric Igel Airway in 250 Children

Anesthesia Clinical Trial

Official title:

A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00969189
• Other study ID #: CH/2008/2808
• Secondary ID: NRES ID: 08/H010
• Status: Terminated
• Phase: N/A
• First received: August 31, 2009
• Last updated: December 14, 2011
• Start date: August 2009
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Child
• Infant

Locations

Country	Name	City	State
United Kingdom	UH Bristol NHS Foundation Trust	Bristol	Avon

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust	Royal United Hospital Bath NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?		during anaesthesia	No
Secondary	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	Yes