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Evaluation of the Pediatric Igel Airway in 250 Children

NCT ID: NCT00969189

Last Updated: 2011-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Child Infant

Keywords

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anesthesia child infant laryngeal mask

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

between 10 and 30 kgs

No interventions assigned to this group

Infants

between 5 - 10 kg

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal United Hospital Bath NHS Trust

OTHER

Sponsor Role collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Michelle White

Consultant in Paediatric Anaesthesia and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle White, MB ChB

Role: PRINCIPAL_INVESTIGATOR

UH Bristol NHS Foundation Trust

Locations

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UH Bristol NHS Foundation Trust

Bristol, Avon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NRES ID: 08/H0101/198

Identifier Type: -

Identifier Source: secondary_id

CH/2008/2808

Identifier Type: -

Identifier Source: org_study_id