Evaluation of the Pediatric Igel Airway in 250 Children

U

University Hospitals Bristol and Weston NHS Foundation Trust

Status

Terminated

Conditions

Child
Infant
Anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT00969189
NRES ID: 08/H0101/198
CH/2008/2808

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

Under 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Children
Description:
between 10 and 30 kgs
Infants
Description:
between 5 - 10 kg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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