Status:

TERMINATED

Evaluation of the Pediatric Igel Airway in 250 Children

Lead Sponsor:

University Hospitals Bristol and Weston NHS Foundation Trust

Collaborating Sponsors:

Royal United Hospital Bath NHS Trust

Conditions:

Anesthesia

Child

Eligibility:

All Genders

Up to 16 years

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2011

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00969189

Start Date

August 1 2009

End Date

March 1 2011

Last Update

December 15 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UH Bristol NHS Foundation Trust

Bristol, Avon, United Kingdom, BS2 8BJ

Evaluation of the Pediatric Igel Airway in 250 Children | DecenTrialz