ChildrenNCT01314248
The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients
An observational study of Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- each child will receive both the LMA and ILA
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children undergoing general anesthesia for their scheduled elective outpatient surgeries using a supraglottic airway device for airway maintenance.
Who may be able to join
- Healthy children undergoing general anesthesia using a supraglottic airway device
- 6 months to 36 months of age
- 10 to 15 kilograms in weight
Who cannot join
- Active respiratory infection
- History of difficult mask ventilation
- Features or history of a difficult airway
- Gastrointestinal reflux disease
- Clinically significant pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: A Randomized Crossover Comparison Between the Air-Q Intubating Laryngeal Airway the Laryngeal Mask Airway-Unique in Children
The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.
Read the detailed description
The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards:
- We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached.
- We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.
- Conditions
- Children
- Being tested
- each child will receive both the LMA and ILA
- Keywords
- airway sealing pressure, fiberoptic assessment, ease and time for successful insertion, incidence of gastric insufflation, complications were also evaluated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
each child will receive both the LMA and ILADevice
each child will receive both the size 2 LMA and size 1.5 ILA
| Study group | Role | What they receive |
|---|---|---|
| children weighing 10 to 15 kg | Not described Receives: Device: each child will receive both the LMA and ILA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Narasimhan Jagannathan, MD, Principal investigator, Childrens Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314248
- Sponsor's protocol ID
- laryngeal mask airway & air Q
- Status last verified
- Jul 2013
- First submitted
- 10 Mar 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15.
PubMed 21917058
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Comparison Between the Air-Q Intubating Laryngeal Airway the Laryngeal Mask Airway-Unique in Children
- ClinicalTrials.gov ID
- NCT01314248
- Acronym / sponsor ID
- laryngeal mask airway & air Q
- Conditions
- Children
- Keywords
- airway sealing pressure, fiberoptic assessment, ease and time for successful insertion, incidence of gastric insufflation, complications were also evaluated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Mar 2011 (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.
The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.
Detailed description
The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards:
- We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached.
- We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children weighing 10 to 15 kg | – | Device: each child will receive both the LMA and ILA |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children undergoing general anesthesia for their scheduled elective outpatient surgeries using a supraglottic airway device for airway maintenance.
Key inclusion criteria (3 listed)
- Healthy children undergoing general anesthesia using a supraglottic airway device
- 6 months to 36 months of age
- 10 to 15 kilograms in weight
Key exclusion criteria (5 listed)
- Active respiratory infection
- History of difficult mask ventilation
- Features or history of a difficult airway
- Gastrointestinal reflux disease
- Clinically significant pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| each child will receive both the LMA and ILAeach child will receive both the size 2 LMA and size 1.5 ILA | Device | children weighing 10 to 15 kg |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 21917058Jagannathan N, Sohn LE, Mankoo R, Langen KE, Mandler T. A randomized crossover comparison between the Laryngeal Mask Airway-Unique and the air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2012 Feb;22(2):161-7. doi: 10.1111/j.1460-9592.2011.03703.x. Epub 2011 Sep 15.
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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.
Narasimhan Jagannathan, MD principal investigator
Childrens Memorial Hospital
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 Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 30 Jul 2013. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314248, which also lists 1 linked publication.
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 30 Jul 2013.