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

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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

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

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.

Conditions: Tracheal Intubation in Children
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 group	Role	What they receive
Ambu Aura-i size 1.5	Experimental	patients 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 1.5	Experimental	patients 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 2	Experimental	patients 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 2	Experimental	patients 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.

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)

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
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
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
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
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
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.

Feb 2012Apr 2012

First posted20 Feb 2012 (estimated)
Study startFeb 2012
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Tracheal Intubation in 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: 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
Results posted: Yes, on ClinicalTrials.gov
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