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

June 27, 2012 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Childrens Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ambu Aura-i size 1.5
patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Device: Ambu Aura-i size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: air-Q size 1.5
patients will receive either the Ambu Aura-i size 1.5 or air-Q ILA 1.5 based on manufacturer recommendations of body weight
Device: air-Q ILA size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: Ambu Aura-i size 2
patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Device: Ambu Aura-i size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Experimental: air-Q size 2
patients will receive either the Ambu Aura-i size 2 or air-Q ILA 2 based on manufacturer recommendations of body weight
Device: air-Q ILA size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ease and 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
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fiberoptic grade of laryngeal view
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The laryngeal alignment through the devices will be graded using an established scoring system
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease and time to place airway
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
From picking up the airway device to bilateral chest expansion and presence of ETCO2
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
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
number of attempts needed for successful placement will be recorded (maximum of 3 attempts; >3 attempts will be considered as a failure)
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway Leak Pressure
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Time to remove device
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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.
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway maneuvers
Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The number and type of various airway maneuvers such as jaw thrust, neck extension, advancement/ withdrawal of the supraglottic device, and/ or anterior Laryngeal Pressure to optimize tracheal intubation will be recorded
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Adverse effects
Time Frame: Participants will be followed for the duration of anesthesia and 24 hours postoperatively
complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded
Participants will be followed for the duration of anesthesia and 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Narasimhan Jagannathan, MD, Ann & Robert H Lurie Children's hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Air-Q versus Ambu-Aura-i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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