Nasotracheal IntubationNCT02267759
McGrath Videolaryngoscopy for Nasotracheal Intubation
A study testing McGrath videolaryngoscopy and Macintosh laryngoscopy in people with Nasotracheal Intubation, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation, thereby reducing intubation time and complications, especially in patients with a difficult airway. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Nasotracheal Intubation
- What is being tested?
- McGrath videolaryngoscopy and Macintosh laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Mar 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients for dental or maxillofacial surgery requiring nasotracheal intubation
Who cannot join
- known difficult airway
- required rapid sequence induction
- history of bleeding
- cervical spine injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of McGrath Videolaryngoscopy and Macintosh Laryngoscopy for Routine Nasotracheal Intubation
McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation, thereby reducing intubation time and complications, especially in patients with a difficult airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as judged by the time to intubation and ease of intubation.
- Conditions
- Nasotracheal Intubation
- Being tested
- McGrath videolaryngoscopy, Macintosh laryngoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath videolaryngoscopyDevice
After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced.
Macintosh laryngoscopyDevice
After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced.
| Study group | Role | What they receive |
|---|---|---|
| McGrath | Experimental | Nasotracheal intubation was performed with McGrath videolaryngoscopy Receives: Device: Macintosh laryngoscopy |
| Macintosh | Active comparator | Nasotracheal intubation was performed with Macintosh direct laryngoscopy Receives: Device: McGrath videolaryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
time the nasotracheal tube was inserted into nares until endtidal CO2 was detected
Measured: 4 min after anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasotracheal 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267759
- Sponsor's protocol ID
- AJIRB-DEV-DE1-14-312
- Status last verified
- Jun 2015
- First submitted
- 14 Oct 2014
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of McGrath Videolaryngoscopy and Macintosh Laryngoscopy for Routine Nasotracheal Intubation
- ClinicalTrials.gov ID
- NCT02267759
- Acronym / sponsor ID
- AJIRB-DEV-DE1-14-312
- Conditions
- Nasotracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Oct 2014 (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.
McGrath videolaryngoscopy avoids the use of Magill forceps for nasotracheal intubation, thereby reducing intubation time and complications, especially in patients with a difficult airway. This study was performed to investigate whether McGrath videolaryngoscopy is superior to Macintosh laryngoscopy for routine nasotracheal intubation in expected normal airways, as judged by the time to intubation and ease of intubation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath | Experimental | Device: Macintosh laryngoscopyNasotracheal intubation was performed with McGrath videolaryngoscopy |
| Macintosh | Active comparator | Device: McGrath videolaryngoscopyNasotracheal intubation was performed with Macintosh direct laryngoscopy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients for dental or maxillofacial surgery requiring nasotracheal intubation
Key exclusion criteria (4 listed)
- known difficult airway
- required rapid sequence induction
- history of bleeding
- cervical spine injury
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 videolaryngoscopyAfter the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced. | Device | Macintosh |
| Macintosh laryngoscopyAfter the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced. | Device | McGrath |
Primary outcome
time to intubation
Time frame: 4 min after anesthetic induction
time the nasotracheal tube was inserted into nares until endtidal CO2 was detected
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 19 Jun 2015.
Related trials for Nasotracheal Intubation
Not yet recruiting
ASIGN Trial- Angulated Versus Standard Video-laryngoscope Blade in Nasal Intubation
Nasal Intubation
Recruiting
Comparison of Awake Tracheal Intubation Methods
Airway Management Assessment, Awake Endotracheal Intubation
Recruiting
Fibrescope vs Videolaryngoscope for Nasotracheal Intubation
No Disease
Recruiting
Nostril Side on Epistaxis
Nasotracheal Intubation
Recruiting
The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation for Deep Sedation Fiberoptic Bronchoscopy
Hypoxia, Pulmonary Nodule
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.
Jong Yeop Kim, 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 videolaryngoscopy and Macintosh laryngoscopy in people with Nasotracheal Intubation, 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 4 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 19 Jun 2015. 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: 4 min after anesthetic induction). 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 19 Jun 2015.