AzTrials
AzTrials

Tracheal Intubation in ChildrenNCT01535742

Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

A study testing Ambu Aura-i size 1.5, air-Q ILA size 1.5 and Ambu Aura-i size 2 in people with Tracheal Intubation in Children, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA. Read more about this study

Who is it for?
Ages 1 month to 6 yearsHealthy volunteers can take part
Conditions the study is for
Tracheal Intubation in Children
What is being tested?
Ambu Aura-i size 1.5, air-Q ILA size 1.5 and Ambu Aura-i size 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Feb 2012to Apr 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 1 month to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children undergoing general anesthesia requiring tracheal intubation
  • Weight 5-20 kg
  • Age one month-six years

Who cannot join

  • American Society of Anesthesiologists (ASA) class IV, V Emergency procedures
  • History of a difficult airway
  • Active upper respiratory tract infection
  • Children receiving emergent surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Childrens Memorial Hospital

    Chicago, Illinois, 60614

Other trials in United States

About this study

Official title: Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children

The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.

Read the detailed description

The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.

Being tested
Ambu Aura-i size 1.5, air-Q ILA size 1.5, Ambu Aura-i size 2, air-Q ILA size 2
Keywords
laryngeal mask airway, children, tracheal intubation, fiberoptic bronchoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambu Aura-i size 1.5Device

    Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

  • air-Q ILA size 1.5Device

    Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

  • Ambu Aura-i size 2Device

    Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

  • air-Q ILA size 2Device

    Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

Study groups in NCT01535742
Study groupRoleWhat they receive
Ambu Aura-i size 1.5Experimentalpatients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Receives: Device: Ambu Aura-i size 1.5
air-Q size 1.5Experimentalpatients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Receives: Device: air-Q ILA size 1.5
Ambu Aura-i size 2Experimentalpatients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Receives: Device: Ambu Aura-i size 2
air-Q size 2Experimentalpatients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Receives: Device: air-Q ILA size 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Successful Tracheal Intubation

    Starting from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed

    Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary outcomes (6)

  1. Time to Airway Placement

    From picking up the airway device to bilateral chest expansion and presence of End-tidal Carbon Dioxide (ETCO2)

    Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  2. Number of Attempts to Place the Supraglottic Device and Tracheal Tube

    Number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >3 attempts will be considered as a failure)

    Measured: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  3. Airway Leak Pressure

    Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely

    Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  4. Fiberoptic Grade of Laryngeal View

    The laryngeal alignment through the devices will be graded using an established scoring system.

    • Grade 1, larynx only seen;
    • Grade 2, larynx and epiglottis posterior surface seen;
    • Grade 3, larynx and epiglottis tip of anterior surface seen, <50% visual obstruction of epiglottis to larynx;
    • Grade 4, epiglottis downfolded and its anterior surface seen, >50% visual obstruction of epiglottis to larynx;
    • Grade 5, epiglottis downfolded and larynx cannot be seen directly

    Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  5. Time to Remove Device

    removal will be done with the use of a removal stylet. Should inadvertent extubation occur during removal of the device, the intubation will be deemed a failure.

    Measured: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  6. Complications

    Complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded

    Measured: Participants will be followed for the duration of when anesthesia was administered until 24 hours postoperatively, an average of 36 hours. Adverse effects were assessed per standard postoperative protocols, an average of up to 3 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01535742
Sponsor's protocol ID
Air-Q versus Ambu-Aura-i
Status last verified
Oct 2026
First submitted
13 Feb 2012
Last updated
16 Oct 2026
Data monitoring committee
No

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

  • Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16.

    PubMed 21081777

  • Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x.

    PubMed 21973052

  • Baker PA, Brunette KE, Byrnes CA, Thompson JM. A prospective randomized trial comparing supraglottic airways for flexible bronchoscopy in children. Paediatr Anaesth. 2010 Sep;20(9):831-8. doi: 10.1111/j.1460-9592.2010.03362.x.

    PubMed 20716075

Questions about this trial

What is this clinical trial studying?

A study testing Ambu Aura-i size 1.5, air-Q ILA size 1.5 and Ambu Aura-i size 2 in people with Tracheal Intubation in 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 4 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 16 Oct 2026. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Successful Tracheal Intubation (time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01535742, which also lists 4 linked publications.

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 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in