Anesthesia, EndotrachealNCT03582787
A Comparison of McGrath MAC Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children With Torticollis
A study testing McGrath MAC videolaryngoscopy and Macintosh Laryngoscopy in people with Anesthesia, Endotracheal, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis. The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Anesthesia, Endotracheal
- What is being tested?
- McGrath MAC videolaryngoscopy and Macintosh Laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2018to 25 May 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- orotracheal intubation under general anesthesia
- torticollis
Who cannot join
- •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Suwon, Seoum
About this study
Official title: Ajou University School of Medicine
The primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis.
The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.
- Conditions
- Anesthesia, Endotracheal
- Being tested
- McGrath MAC videolaryngoscopy, Macintosh Laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MAC videolaryngoscopyDevice
Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction
Macintosh LaryngoscopyDevice
Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| Mcgrath group | Experimental | Orotracheal intubation with McGrath MAC videolaryngoscopy Receives: Device: McGrath MAC videolaryngoscopy |
| Macintosh group | Placebo comparator | Orotracheal intubation with Macintosh laryngoscopy Receives: Device: Macintosh Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2
Measured: through intubation completion, an average of 30 second
Secondary outcomes (1)
The degree of glottic exposure as assessed by Cormack and Lehane Grade
Grade 1: full view of glottis, grade 2: Partial view of glottis, grade 3:only epiglottis seen, grade 4:neither glottis nor epiglottis seen
Measured: Up to 5 second after laryngoscopy passing the teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start31 May 2018
- Primary completion25 May 2019
- Study completion25 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EndotrachealStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Eun Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582787
- Sponsor's protocol ID
- AJIRB-MED-OBS-18-106
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ajou University School of Medicine
- ClinicalTrials.gov ID
- NCT03582787
- Acronym / sponsor ID
- AJIRB-MED-OBS-18-106
- Conditions
- Anesthesia, Endotracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 11 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 primary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on the intubation time for orotracheal intubation in children with torticollis.
The secondary purpose of this study is to investigate the effects of McGrath MAC videolaryngoscopy on Cormack and Lehane Grade for orotracheal intubation in children with torticollis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mcgrath group | Experimental | Device: McGrath MAC videolaryngoscopyOrotracheal intubation with McGrath MAC videolaryngoscopy |
| Macintosh group | Placebo comparator | Device: Macintosh LaryngoscopyOrotracheal intubation with Macintosh laryngoscopy |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- orotracheal intubation under general anesthesia
- torticollis
Key exclusion criteria (1 listed)
- •oral lesions, congenital anomaly, cervical spine instability, rapid sequence intubation
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 |
|---|---|---|
| McGrath MAC videolaryngoscopyOrotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction | Device | Mcgrath group |
| Macintosh LaryngoscopyOrotracheal intubation with Macintosh Laryngoscopy after anesthetic induction | Device | Macintosh group |
Primary outcome
Intubation time
Time frame: through intubation completion, an average of 30 second
Time interval between laryngoscopy passing the teeth to the confirming of end tidal CO2
1 secondary outcome
The degree of glottic exposure as assessed by Cormack and Lehane Grade
Time frame: Up to 5 second after laryngoscopy passing the teeth
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 5 Jul 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 McGrath MAC videolaryngoscopy and Macintosh Laryngoscopy in people with Anesthesia, Endotracheal, 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 2 inclusion and 1 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 5 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 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. Some participants in this study may receive a placebo. 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: through intubation completion, an average of 30 second). 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 5 Jul 2019.