A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways

February 2, 2015 updated by: Helena Karlberg, Baylor College of Medicine

A Comparison Between Two Video Laryngoscopes,the Truview PCD and the Glidescope Cobalt AVL, in Successfully Intubating Pediatric Mannequins With and Without Difficult Airways

The study is a randomized crossover study where anesthesia practitioners will intubate three different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome anatomy) using three different intubation devices (the Miller blade, the Truview VL, the Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an immobile neck). The order of presentation will be randomized. As this is a cross over study, all subjects will complete all scenarios. There is no placebo group, and each subject wil be his or her own control.

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

Participants will be given individual, standardized instructions and demonstrations for each device as per the manufacturers' instructions. The participants will practice with instructor's feedback on an infant mannequin with a normal airway until he/she feel comfortable with each of the three devices. The investigator will record the prior experience of the participant in using each of the 3 devices in clinical situations. Each subject will be asked to intubate each of the mannequins with each of the devices. The choice of the order of device and mannequin will be based on a Latin square design and the sequence will be assigned to participants based on a computer generated random number. A closed envelope technique will blind participants and investigators to the order of airway device and mannequin till the start of the individual trial. Participants will first finish the test on unchanged conditions and then repeat the process using the same order of mannequins and devices but with the neck held immobile to simulate a scenario of a child with an unstable cervical spine. Data from different scenarios will be recorded from a total number of 18 attempts of tracheal intubation per participant. Participants will be asked to proceed as though they were in the operating room with an assistant available to follow their commands. The order of presentation of each mannequin, airway device and scenario will be randomized as described above. The time from placing the device in the mannequin's mouth to the time the Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given will constitute the intubation time. During each intubation the participant will be asked to state when he or she has obtained the best view for intubation and this time this will be recorded as the time for visualization. The subject will assess the quality of the best glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction, pulling the tongue forward etc. The time from entry of the device in the mouth to the time the tracheal tube is started to be advanced is the visualization time. The time a positive pressure breath is given at the end of the tracheal tube will constitute the end of the attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the mouth without a successful intubation. The number of times the endotracheal tube is advanced will also be recorded. Failure of intubation will be defined as unrecognized esophageal intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation requiring more than 3 attempts. The observer will estimate the maximum force applied to the maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10 scale.

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.
30

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.
  • Phase 1

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
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children't 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of >500 intubations with Miller blades.

Exclusion Criteria:

  • Anesthesia practitioners with <500 intubations with Miller blades.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • 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.
Active Comparator: Miller blade
Subjects must have >500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control.
Device: Miller blade
To participate in the study the subjects must have >500 intubations with the miller blade.
Active Comparator: Truview PCD
Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control.
Device: Truview PCD
Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.
Other Names:
  • Trueview PCD - Multichoice video laryngoscope system
Active Comparator: Glidescope Cobolt
Subjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.
Device: Glidescope Cobolt
Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.

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 required for successful endotracheal intubation with the three devices.
Time Frame: Subjects complete study in 1 day
The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says "begin" until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.
Subjects complete study in 1 day

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
Time to visualize the larynx
Time Frame: From time recorder says "begin" till subject rates best view up to 3minutes
Start time is when the recorder says "begin" . The time to visualize the larynx ends when the subject rates best view of the larynx.
From time recorder says "begin" till subject rates best view up to 3minutes
Time from visualization of larynx to tracheal intubation
Time Frame: one day
time from the beginning of the endotracheal tube being inserted till first positive pressure breath measured in seconds.
one day
Number of attempts at tracheal intubation
Time Frame: one day
Subjects were allowed a total of 3 attempts at tracheal intubation with a device on a mannequin.
one day
Number of failed attempts
Time Frame: one day
Subjects were allowed 3 unsuccessful attempts with each device. After 3 unsuccessful attempts with a device the subject was considered to have failed that device.
one day
Amount of force on the maxilla
Time Frame: one day
Observer rated the amount of force on the maxilla based on a 0-10 point scale. The observer was the same for all cases.
one day
Optimization measures for laryngeal visualization and tracheal intubation
Time Frame: one day
The subjects were allowed to ask for assistance with optimization such as external tracheal pressure, lip retraction, or pulling on the tongue. All subjects were instructed that no measures would be taken unless asked for and intructed on what assistance was needed. The observer recorded and counted all optimizing measures.
one day
Documentation of participant's comments on preference of device
Time Frame: one day
All participants were asked at the completion of the study what device they prefered for a case with anticipated difficult intubation. A count was made of their preference.
one day

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.
Baylor College of Medicine

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.
November 1, 2014

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.
December 1, 2014

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).
January 15, 2014

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.
July 23, 2014

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.
July 24, 2014

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.
February 3, 2015

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.
February 2, 2015

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.
February 1, 2015

More Information

Terms related to this study

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.
  • H28224

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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