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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

120

Phase

  • 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

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
Intervention / Treatment
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

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

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

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • 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

February 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 15, 2012

First Posted (Estimate)

February 20, 2012

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Tracheal Intubation in Children

Clinical Trials on Ambu Aura-i size 1.5

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe