Intubation TimeNCT02828631
A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics
A study testing Macintosh laryngoscope, McGrath videolaryngoscope and Pentax videolaryngoscope in people with Intubation Time and Intubation Difficulty Scale, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Intubation Time, Intubation Difficulty Scale
- What is being tested?
- Macintosh laryngoscope, McGrath videolaryngoscope and Pentax videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Oct 2017
- 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 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologist physical status class I, II
Who cannot join
- abnormality of airway
- bleeding tendency
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou universitiy school of medicine
Suwon, Gyeong-gi Do, 16499
About this study
Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.
- Conditions
- Intubation Time, Intubation Difficulty Scale
- Being tested
- Macintosh laryngoscope, McGrath videolaryngoscope, Pentax videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
McGrath videolaryngoscopeDevice
Pentax videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Nasotracheal intubation by Macintosh laryngoscope Receives: Device: Macintosh laryngoscope |
| McGrath videolaryngoscope | Experimental | Nasotracheal intubation by McGrath videolaryngoscope Receives: Device: McGrath videolaryngoscope |
| Pentax videolaryngoscope | Experimental | Nasotracheal intubation by Pentax videolaryngoscope Receives: Device: Pentax videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Time from nasotracheal tube passing nose until confirmation of tracheal intubation by end-tidal carbon dioxide will be measured
Measured: 2 min
Secondary outcomes (1)
intubation difficulty scale
Modified nasal intubation difficulty scale will be assessed : N1(intubation attempts), N2(operators to attempt intubation, N3(alternative intubation techniques or change head position), N4(glottic exposure), N5(lifting force required to expose the vocal cords), N6(optimise glottic exposure with backward, upward and right ward pressure), N7(techniques to aid intubation)
Measured: immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation TimeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yun jeong chae, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828631
- Sponsor's protocol ID
- AJIRB-MED-OBS-16-145
- Status last verified
- Jan 2019
- First submitted
- 30 Jun 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics
- ClinicalTrials.gov ID
- NCT02828631
- Acronym / sponsor ID
- AJIRB-MED-OBS-16-145
- Conditions
- Intubation Time, Intubation Difficulty Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Jul 2016 (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.
Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Device: Macintosh laryngoscopeNasotracheal intubation by Macintosh laryngoscope |
| McGrath videolaryngoscope | Experimental | Device: McGrath videolaryngoscopeNasotracheal intubation by McGrath videolaryngoscope |
| Pentax videolaryngoscope | Experimental | Device: Pentax videolaryngoscopeNasotracheal intubation by Pentax videolaryngoscope |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist physical status class I, II
Key exclusion criteria (2 listed)
- abnormality of airway
- bleeding tendency
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 laryngoscope | Device | Macintosh laryngoscope |
| McGrath videolaryngoscope | Device | McGrath videolaryngoscope |
| Pentax videolaryngoscope | Device | Pentax videolaryngoscope |
Primary outcome
time to intubation
Time frame: 2 min
Time from nasotracheal tube passing nose until confirmation of tracheal intubation by end-tidal carbon dioxide will be measured
1 secondary outcome
intubation difficulty scale
Time frame: immediately after intubation
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 10 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, McGrath videolaryngoscope and Pentax videolaryngoscope in people with Intubation Time and Intubation Difficulty Scale, run by Ajou University School of Medicine at 1 site in South Korea.
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 1 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 10 Jan 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 South Korea. 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?
time to intubation (time frame: 2 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2019.