Comparison of Fiberoptic Intubation With Fiberoptic Intubation Through an Air-Q Intubating Laryngeal Airway in Infants and Small Children

July 29, 2013 updated by: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

A Randomized Comparison of Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?

The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?

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 aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal 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.
80

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, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago

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 day to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
  • Age 1 month - 2 years
  • Weight 1-20 Kg

Exclusion Criteria:

  • Children with active respiratory infection
  • Known history of difficult mask ventilation
  • Diagnosis of a congenital syndrome associated with difficult airway management
  • Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).

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: None (Open Label)

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.
Active Comparator: Fiberoptic Intubation performed by an expert
Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q
Device: air-Q, followed by fiberoptic intubation
Other Names:
  • Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Device: Free-hand Fiberoptic Intubation
Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed
Experimental: Fiberoptic Intubation performed by a novice
Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q
Device: air-Q, followed by fiberoptic intubation
Other Names:
  • Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
Device: Free-hand Fiberoptic Intubation
Fiberoptic tracheal intubation will be performed without use of the air-Q 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
Time for successful fiberoptic tracheal intubation
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is 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
Time to successful placement of the Air-Q
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Successful placement of the air-Q will start with the removal of the facemask until presence of end-tidal CO2 is confirmed.
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of attempts to place the Air-Q
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 will be considered as a failure)
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease for placement of the air-Q
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The ease for Air-Q placement will be assessed using a subjective scale
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Peri-operative complications
Time Frame: Measured at 24 hours after device placement/study initiation
Includes: Complications during the placement of the Air-Q (Laryngospasm, Bronchospasm, Desaturation, etc. Oropharyngolaryngeal morbidity at discharge, participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours. Oropharyngolaryngeal morbidity at 24 hours post-operatively, measured at 24 hours after device placement/study initiation. These will be assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Measured at 24 hours after device placement/study initiation
Number of attempts for fiberoptic tracheal intubation
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 fiberoptic tracheal intubation will be recorded (maximum of 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
Ease for fiberoptic tracheal intubation
Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The ease for fiberoptic tracheal intubation will be assessed using a subjective scale
Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

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
  • Principal Investigator: Lisa Sohn, 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.
June 1, 2013

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.
July 1, 2013

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.
July 1, 2013

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).
June 11, 2013

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.
June 12, 2013

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.
June 13, 2013

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.
July 30, 2013

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.
July 29, 2013

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.
July 1, 2013

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.
  • IRB#2013-15391

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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