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Evaluation of the Pediatric Igel Airway in 250 Children

This study has been terminated.
(Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited)
Sponsor:
Collaborator:
Royal United Hospital Bath NHS Trust
Information provided by (Responsible Party):
Michelle White, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier:
NCT00969189
First received: August 31, 2009
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition
Anesthesia
Child
Infant

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants

Resource links provided by NLM:


Further study details as provided by University Hospitals Bristol NHS Foundation Trust:

Primary Outcome Measures:
  • Does the i−gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? [ Time Frame: during anaesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post−operative sequelae [ Time Frame: during anaesthesia and up to 24 hours postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
between 10 and 30 kgs
Infants
between 5 - 10 kg

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

children between 10 - 30 kgs infants between 5-10 kgs

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969189

Locations
United Kingdom
UH Bristol NHS Foundation Trust
Bristol, Avon, United Kingdom, BS2 8BJ
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
Royal United Hospital Bath NHS Trust
Investigators
Principal Investigator: Michelle White, MB ChB UH Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Michelle White, Consultant in Paediatric Anaesthesia and Critical Care, University Hospitals Bristol NHS Trust
ClinicalTrials.gov Identifier: NCT00969189     History of Changes
Other Study ID Numbers: CH/2008/2808, NRES ID: 08/H0101/198
Study First Received: August 31, 2009
Last Updated: December 14, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University Hospitals Bristol NHS Foundation Trust:
anesthesia
child
infant
laryngeal mask

ClinicalTrials.gov processed this record on November 24, 2014