Intubation;DifficultNCT03337555
A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation
A study testing McGrath, Pentax and Macintosh in people with Intubation;Difficult, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Intubation;Difficult
- What is being tested?
- McGrath, Pentax and Macintosh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2017to 20 Feb 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 19 years old
- ASA I or II
- Patients who need nasotracheal intubation for surgery
Who cannot join
- Anatomical deformity in head and neck
- Modified Mallampati score IV
- Bleeding tendency in preoperative evaluation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university schoole of medicine
Suwon, Gyeonggi-do, 16499
About this study
A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes
Read the detailed description
This trial is prospective randomized trial. The Objects are adult patients who need nasotracheal intubation for surgery. Using computed randomized table, participants are assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.
The intubation will be done by One expert anesthesiologist who have more than 10 years experience.
Investigators compare intubation time, success rate and difficulty between three groups.
- Conditions
- Intubation;Difficult
- Being tested
- McGrath, Pentax, Macintosh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrathDevice
McGrath videolaryngoscope
PentaxDevice
Pentax videolaryngoscope
MacintoshDevice
Macintosh direct laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Macintosh | Active comparator | intubation using Macintosh direct laryngoscope Receives: Device: Macintosh |
| McGrath | Experimental | intubation using McGrath MAC® Receives: Device: McGrath |
| Pentax | Experimental | intubation using Pentax-airway scope® Receives: Device: Pentax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation time
from endotracheal tube pass the nostril to end-tidal CO2 appear
Measured: within 5 minutes
Secondary outcomes (1)
Success rate
Failure defined intubation time more than 120sec or SaO2 less than 95%
Measured: within 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start7 Nov 2017
- Primary completion30 Jan 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- Yun Jeong Chae, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337555
- Sponsor's protocol ID
- AJIRB-MED-OBS-17-327
- Status last verified
- Jul 2019
- First submitted
- 6 Nov 2017
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of McGrath MAC®, Pentax-AWS® and Macintosh Direct Laryngoscopes for Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT03337555
- Acronym / sponsor ID
- AJIRB-MED-OBS-17-327
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 9 Nov 2017 (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.
A comparison of intubation time, difficulty of intubation in nasotracheal intubation using McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes
Detailed description
This trial is prospective randomized trial. The Objects are adult patients who need nasotracheal intubation for surgery. Using computed randomized table, participants are assigned to three groups, McGrath MAC®, Pentax-AWS® and Macintosh direct laryngoscopes.
The intubation will be done by One expert anesthesiologist who have more than 10 years experience.
Investigators compare intubation time, success rate and difficulty between three groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Macintosh | Active comparator | Device: Macintoshintubation using Macintosh direct laryngoscope |
| McGrath | Experimental | Device: McGrathintubation using McGrath MAC® |
| Pentax | Experimental | Device: Pentaxintubation using Pentax-airway scope® |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 19 years old
- ASA I or II
- Patients who need nasotracheal intubation for surgery
Key exclusion criteria (3 listed)
- Anatomical deformity in head and neck
- Modified Mallampati score IV
- Bleeding tendency in preoperative evaluation
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 |
|---|---|---|
| McGrathMcGrath videolaryngoscope | Device | McGrath |
| PentaxPentax videolaryngoscope | Device | Pentax |
| MacintoshMacintosh direct laryngoscope | Device | Macintosh |
Primary outcome
Intubation time
Time frame: within 5 minutes
from endotracheal tube pass the nostril to end-tidal CO2 appear
1 secondary outcome
Success rate
Time frame: within 5 minutes
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 25 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Yun Jeong Chae, MD principal investigator
Ajou University School of Medicine
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, Pentax and Macintosh in people with Intubation;Difficult, 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 3 inclusion and 3 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 25 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. 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: within 5 minutes). 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 25 Jul 2019.