Tracheal IntubationNCT02384564
King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
A study testing Ambu King Vision Video Laryngoscope aBlade and Direct Laryngoscopy via Miller Straight Blade in people with Tracheal Intubation, run by Ann & Robert H Lurie Children's Hospital of Chicago.
Trial summary
The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children. Read more about this study
- Who is it for?
- Ages 1 day to 11 years
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Ambu King Vision Video Laryngoscope aBlade and Direct Laryngoscopy via Miller Straight Blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 day to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA (American Society of Anesthesiologists) I-III classified patients
- Patients undergoing procedure where an endotracheal tube would be normally utilized
Who cannot join
- Children with expected difficult airways
- Coagulopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.
Read the detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.
- Conditions
- Tracheal Intubation
- Being tested
- Ambu King Vision Video Laryngoscope aBlade, Direct Laryngoscopy via Miller Straight Blade
- Keywords
- Laryngoscopy, Video Laryngoscopy, Tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu King Vision Video Laryngoscope aBladeDevice
Also called King Vision Video Laryngoscope
At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
Direct Laryngoscopy via Miller Straight BladeDevice
Also called Miller Blade, Wisconsin blade, Straight blade
At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Ambu King Vision Video Laryngoscope aBlade System | Experimental | The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement. Receives: Device: Ambu King Vision Video Laryngoscope aBlade |
| Direct Laryngoscope | Active comparator | The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement. Receives: Device: Direct Laryngoscopy via Miller Straight Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate of Tracheal Intubation
An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.
Measured: Assessed intraoperatively at time of intubation
Secondary outcomes (5)
Grades of Laryngeal View
Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope.
Measured: Assessed intraoperatively at time of intubation
Time to Successful Intubation
The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt.
Measured: Assessed intraoperatively at time of intubation
Intraoperative Complications
Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured.
Measured: Assessed intraoperatively for the duration of the surgery
Postoperative Complications
Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be measured during the post-operative period.
Measured: Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.
Ease of Endotracheal Tube Passage
The ease of tracheal tube passage will be measured following tracheal intubation.
Measured: Assessed intraoperatively at time of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- narasimhan jagannathan, MD, Principal investigator, Ann & Robert Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384564
- Sponsor's protocol ID
- IRB 2015-304
- Status last verified
- Jul 2015
- First submitted
- 26 Feb 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
PubMed 20674088Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
PubMed 23556410Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
PubMed 24742495Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
PubMed 23812581
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
- ClinicalTrials.gov ID
- NCT02384564
- Acronym / sponsor ID
- IRB 2015-304
- Conditions
- Tracheal Intubation
- Keywords
- Laryngoscopy, Video Laryngoscopy, Tracheal intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.
Detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu King Vision Video Laryngoscope aBlade System | Experimental | Device: Ambu King Vision Video Laryngoscope aBladeThe trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement. |
| Direct Laryngoscope | Active comparator | Device: Direct Laryngoscopy via Miller Straight BladeThe trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement. |
Who may qualify
- Ages
- 1 day to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) I-III classified patients
- Patients undergoing procedure where an endotracheal tube would be normally utilized
Key exclusion criteria (2 listed)
- Children with expected difficult airways
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu King Vision Video Laryngoscope aBladeAlso: King Vision Video LaryngoscopeAt time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed. | Device | Ambu King Vision Video Laryngoscope aBlade System |
| Direct Laryngoscopy via Miller Straight BladeAlso: Miller Blade, Wisconsin blade, Straight bladeAt time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed. | Device | Direct Laryngoscope |
Primary outcome
First Attempt Success Rate of Tracheal Intubation
Time frame: Assessed intraoperatively at time of intubation
An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.
5 secondary outcomes
Grades of Laryngeal View
Time frame: Assessed intraoperatively at time of intubation
Time to Successful Intubation
Time frame: Assessed intraoperatively at time of intubation
Intraoperative Complications
Time frame: Assessed intraoperatively for the duration of the surgery
Postoperative Complications
Time frame: Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour.
Ease of Endotracheal Tube Passage
Time frame: Assessed intraoperatively at time of intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Background: PubMed 20674088Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31.
- Background: PubMed 23556410Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
- Background: PubMed 24742495Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
- Background: PubMed 23812581Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
narasimhan jagannathan, MD principal investigator
Ann & Robert Lurie Children's Hospital of Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Ambu King Vision Video Laryngoscope aBlade and Direct Laryngoscopy via Miller Straight Blade in people with Tracheal Intubation, run by Ann & Robert H Lurie Children's Hospital of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Narasimhan Jagannathan, MD (312275170, njagannathan@luriechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt Success Rate of Tracheal Intubation (time frame: Assessed intraoperatively at time of intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384564, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.