AnesthesiaNCT00969189
Evaluation of the Pediatric Igel Airway in 250 Children
An observational study of Anesthesia and Child, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Child, Infant
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children between 10 - 30 kgs infants between 5-10 kgs
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
UH Bristol NHS Foundation Trust
Bristol, Avon, BS2 8BJ
About this study
Official title: A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
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.
- Conditions
- Anesthesia, Child, Infant
- Keywords
- anesthesia, child, infant, laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | between 10 and 30 kgs | |
| Infants | between 5 - 10 kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
Measured: during anaesthesia
Secondary outcomes (1)
Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae
Measured: during anaesthesia and up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal United Hospital Bath NHS Trust
- Responsible party
- Principal investigator, Michelle White, University Hospitals Bristol and Weston NHS Foundation Trust
- Investigators
- Michelle White, MB ChB, Principal investigator, UH Bristol NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969189
- Sponsor's protocol ID
- CH/2008/2808
- Other IDs
- NRES ID: 08/H0101/198
- Status last verified
- Dec 2011
- First submitted
- 31 Aug 2009
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
- ClinicalTrials.gov ID
- NCT00969189
- Acronym / sponsor ID
- CH/2008/2808
- Conditions
- Anesthesia, Child, Infant
- Keywords
- anesthesia, child, infant, laryngeal mask
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal United Hospital Bath NHS Trust
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | –between 10 and 30 kgs |
| Infants | – | –between 5 - 10 kg |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children between 10 - 30 kgs infants between 5-10 kgs
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
Time frame: during anaesthesia
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle White, MB ChB principal investigator
UH Bristol NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Child, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Initial number of 250 was not based on sample size. Most airway studies use n=100 therefore trial stopped when 120 children recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? (time frame: during anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.