Endotracheal IntubationNCT03602183
Pediatric Intubation During Emergency Conditions
A study testing Macintosh laryngoscope, Miller laryngoscope and McGrath MAC EMS in people with Endotracheal Intubation and Pediatric, run by Lazarski University at 1 site in Poland.
Trial summary
The effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Pediatric, Cardiac Arrest
- What is being tested?
- Macintosh laryngoscope, Miller laryngoscope and McGrath MAC EMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 sitePoland
- Study dates
- 27 Jul 2018to 20 Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- paramedics
- give voluntary consent to participate in the study
- none experience in videolaryngoscopy
- less than 1 year experience in medicine
Who cannot join
- not meet the above criteria
- wrist or low back diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios
The effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is more difficult than for adults. Also, higher oxygen metabolism requires the immediate response of medical personnel to children in case of need to protect the airways and support breath.
- Conditions
- Endotracheal Intubation, Pediatric, Cardiac Arrest, Injuries
- Being tested
- Macintosh laryngoscope, Miller laryngoscope, McGrath MAC EMS, GlideScope
- Keywords
- difficult airway, endotracheal intubation, chest compression, physician
- Medical subject headings
- Heart Arrest, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
Also called MAC
intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
Miller laryngoscopeDevice
Also called MIL
intubation will be performed using Miller laryngoscope
McGrath MAC EMSDevice
Also called McGrath
intubation will be performed using McGrath MAC EMS video - laryngoscope
GlideScopeDevice
Also called GLS
intubation will be performed using GlideScope video - laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Normal airway scenario | Experimental | intubation in normal airway scenario Receives: Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope |
| Tongue edema scenario | Experimental | intubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators Receives: Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope |
| Spinal immobilization with normal airway scenario | Experimental | intubation in spinal immobilization with normal airway scenario Receives: Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope |
| Spinal immobilization with tongue edema scenario | Experimental | endotracheal intubation with immobilized cervical spine and tongue edema scenario Receives: Device: Macintosh laryngoscope; Device: Miller laryngoscope; Device: McGrath MAC EMS; Device: GlideScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
time in seconds required for a successful intubation attempt
Measured: 1 day
Secondary outcomes (5)
Success of intubation
If the oesopharyngeal tube was incorrectly placed or intubation lasted longer than 60 seconds, the airway-management attempt was defined as a failure.
Measured: 1 day
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading, scale developed by Cormack and Lehane, based on four degrees of visibility of the glottis.
Measured: 1 day
POGO score - percentage of glottic opening
self-reported percentage the vocal cord visualization. A 100% POGO score is a full view of the glottis from the anterior commissure to the interarytenoid notch. A POGO score of 0 means that even the interarytenoid notch is not seen.
Measured: 1 day
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life resuscitation.
Measured: 1 day
Ease of use
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start27 Jul 2018
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endotracheal 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lazarski University
- Sponsor type
- University, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic, Medical University of Vienna
- Responsible party
- Principal investigator, Łukasz Szarpak, Lazarski University
- Investigators
- Lukasz Szarpak, PhD, Principal investigator, Lazarski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602183
- Sponsor's protocol ID
- ETI_2018_PALS
- Status last verified
- Jul 2019
- First submitted
- 29 Jun 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be available from the main investigator
Publications
Szarpak L, Karczewska K, Czyzewski L, Truszewski Z, Kurowski A. Airtraq Laryngoscope Versus the Conventional Macintosh Laryngoscope During Pediatric Intubation Performed by Nurses: A Randomized Crossover Manikin Study With Three Airway Scenarios. Pediatr Emerg Care. 2017 Nov;33(11):735-739. doi: 10.1097/PEC.0000000000000741.
PubMed 27228145Madziala M, Smereka J, Dabrowski M, Leung S, Ruetzler K, Szarpak L. A comparison of McGrath MAC(R) and standard direct laryngoscopy in simulated immobilized cervical spine pediatric intubation: a manikin study. Eur J Pediatr. 2017 Jun;176(6):779-786. doi: 10.1007/s00431-017-2909-9. Epub 2017 Apr 21.
PubMed 28429117Szarpak L, Kurowski A, Czyzewski L, Rodriguez-Nunez A. Video rigid flexing laryngoscope (RIFL) vs Miller laryngoscope for tracheal intubation during pediatric resuscitation by paramedics: a simulation study. Am J Emerg Med. 2015 Aug;33(8):1019-24. doi: 10.1016/j.ajem.2015.04.054. Epub 2015 Apr 30.
PubMed 25979300
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Direct vs. Video-laryngoscopes for Different Emergency Pediatric Airway Scenarios
- ClinicalTrials.gov ID
- NCT03602183
- Acronym / sponsor ID
- ETI_2018_PALS
- Conditions
- Endotracheal Intubation, Pediatric, Cardiac Arrest, Injuries
- Keywords
- difficult airway, endotracheal intubation, chest compression, physician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Lazarski UniversityUniversity, hospital or other
- Collaborators
- Wroclaw Medical University, The Cleveland Clinic, Medical University of Vienna
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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 effectiveness of endotracheal intubation in pre-hospital conditions is insufficient - especially in the context of pediatric patients. Anatomical differences in pediatric patients compared to adults: a relative larger tongue, a larger and more flabby epiglottis - located more cephalously - that make intubation is more difficult than for adults. Also, higher oxygen metabolism requires the immediate response of medical personnel to children in case of need to protect the airways and support breath.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal airway scenario | Experimental | Device: Macintosh laryngoscope, Device: Miller laryngoscope, Device: McGrath MAC EMS, Device: GlideScopeintubation in normal airway scenario |
| Tongue edema scenario | Experimental | Device: Macintosh laryngoscope, Device: Miller laryngoscope, Device: McGrath MAC EMS, Device: GlideScopeintubation in the tongue edema scenario. Tongue edema was obtain using simulator indicators |
| Spinal immobilization with normal airway scenario | Experimental | Device: Macintosh laryngoscope, Device: Miller laryngoscope, Device: McGrath MAC EMS, Device: GlideScopeintubation in spinal immobilization with normal airway scenario |
| Spinal immobilization with tongue edema scenario | Experimental | Device: Macintosh laryngoscope, Device: Miller laryngoscope, Device: McGrath MAC EMS, Device: GlideScopeendotracheal intubation with immobilized cervical spine and tongue edema scenario |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- paramedics
- give voluntary consent to participate in the study
- none experience in videolaryngoscopy
- less than 1 year experience in medicine
Key exclusion criteria (2 listed)
- not meet the above criteria
- wrist or low back diseases
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 |
|---|---|---|
| Macintosh laryngoscopeAlso: MACintubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope | Device | Normal airway scenario, Spinal immobilization with normal airway scenario, Spinal immobilization with tongue edema scenario, Tongue edema scenario |
| Miller laryngoscopeAlso: MILintubation will be performed using Miller laryngoscope | Device | Normal airway scenario, Spinal immobilization with normal airway scenario, Spinal immobilization with tongue edema scenario, Tongue edema scenario |
| McGrath MAC EMSAlso: McGrathintubation will be performed using McGrath MAC EMS video - laryngoscope | Device | Normal airway scenario, Spinal immobilization with normal airway scenario, Spinal immobilization with tongue edema scenario, Tongue edema scenario |
| GlideScopeAlso: GLSintubation will be performed using GlideScope video - laryngoscope | Device | Normal airway scenario, Spinal immobilization with normal airway scenario, Spinal immobilization with tongue edema scenario, Tongue edema scenario |
Primary outcome
Intubation time
Time frame: 1 day
time in seconds required for a successful intubation attempt
5 secondary outcomes
Success of intubation
Time frame: 1 day
Cormack-Lehane grading
Time frame: 1 day
POGO score - percentage of glottic opening
Time frame: 1 day
Preferred ETI device
Time frame: 1 day
Ease of use
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Background: PubMed 27228145Szarpak L, Karczewska K, Czyzewski L, Truszewski Z, Kurowski A. Airtraq Laryngoscope Versus the Conventional Macintosh Laryngoscope During Pediatric Intubation Performed by Nurses: A Randomized Crossover Manikin Study With Three Airway Scenarios. Pediatr Emerg Care. 2017 Nov;33(11):735-739. doi: 10.1097/PEC.0000000000000741.
- Background: PubMed 28429117Madziala M, Smereka J, Dabrowski M, Leung S, Ruetzler K, Szarpak L. A comparison of McGrath MAC(R) and standard direct laryngoscopy in simulated immobilized cervical spine pediatric intubation: a manikin study. Eur J Pediatr. 2017 Jun;176(6):779-786. doi: 10.1007/s00431-017-2909-9. Epub 2017 Apr 21.
- Background: PubMed 25979300Szarpak L, Kurowski A, Czyzewski L, Rodriguez-Nunez A. Video rigid flexing laryngoscope (RIFL) vs Miller laryngoscope for tracheal intubation during pediatric resuscitation by paramedics: a simulation study. Am J Emerg Med. 2015 Aug;33(8):1019-24. doi: 10.1016/j.ajem.2015.04.054. Epub 2015 Apr 30.
- Individual participant dataSharing planned: Undecided. data will be available from the main investigator
Related trials for Endotracheal Intubation
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingObservational study
Patient State Index at Laryngoscopy and Tracheal Intubation Conditions
Anesthesia, Intubation, Endotracheal
Not yet recruitingObservational study
A Novel Score for Procedural Difficulty During Videolaryngoscopic Intubation
Intubation, Intratracheal, Airway Management
Not yet recruiting
Low-Cost Model Versus Airway Part-Task Trainer for Flexible Bronchoscope-Guided Tracheal Intubation Training
Simulation Based Medical Education, Tracheal Intubation
RecruitingObservational study
Predicting High-Flow Nasal Oxygen Failure Within 72 Hours Using a Physiology-Informed Dual-Domain Model at 30 Minutes
Acute Respiratory Failure, Electrical Impedance Tomography (EIT)
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.
Lukasz Szarpak, PhD principal investigator
Lazarski University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope, Miller laryngoscope and McGrath MAC EMS in people with Endotracheal Intubation and Pediatric, run by Lazarski University at 1 site in Poland.
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 4 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: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation time (time frame: 1 day). 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 NCT03602183, which also lists 3 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 31 Jul 2019.