Evaluation of the Pediatric Igel Airway in 250 Children

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00969189

Enrollment

120

Registered

2009-09-01

Start date

2009-08-31

Completion date

2011-03-31

Last updated

2011-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Child, Infant

Keywords

anesthesia, child, infant, laryngeal mask

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 16 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?	during anaesthesia

Secondary

Measure	Time frame
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

Countries

United Kingdom

Outcome results