Oral SurgeryNCT02647606
Comparison of the Videolaryngoscopes With Manual In-line Stabilization
A study testing MILS, McGrath videolaryngoscope and Pentax AWS videolaryngoscope in people with Oral Surgery and Maxillofacial Surgery, run by Ajou University School of Medicine.
Trial summary
Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Oral Surgery, Maxillofacial Surgery
- What is being tested?
- MILS, McGrath videolaryngoscope and Pentax AWS videolaryngoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Feb 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- oral or maxillofacial surgery
- ASA class I, II
Who cannot join
- anticipated difficult intubation
- necessity for rapid sequence induction
- cervical spine injury
- bleeding tendency
About this study
Official title: Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization
Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.
- Conditions
- Oral Surgery, Maxillofacial Surgery
- Being tested
- MILS, McGrath videolaryngoscope, Pentax AWS videolaryngoscope, Macintosh laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILSProcedure or surgery
MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.
McGrath videolaryngoscopeDevice
McGrath videolaryngoscope will be used for intubation
Pentax AWS videolaryngoscopeDevice
Pentax AWS videolaryngoscope will be used for intubation
Macintosh laryngoscopeDevice
Macintosh laryngoscope will be used for intubation
| Study group | Role | What they receive |
|---|---|---|
| McGrath Group | Experimental | MgGrath videolaryngoscope will be used for nasotracheal intubation with MILS Receives: Procedure: MILS; Device: McGrath videolaryngoscope |
| Pentax-AWS Group | Experimental | Pentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS Receives: Procedure: MILS; Device: Pentax AWS videolaryngoscope |
| Macintosh Laryngoscope Group | Experimental | Macintosh Laryngoscope will be used for nasotracheal intubation with MILS Receives: Procedure: MILS; Device: Macintosh laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for intubation
Measured: from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
Cormack Lehane Laryngeal view
Measured: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
POGP score
Percentage of glottic opening(POGO)
Measured: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Secondary outcomes (5)
external laryngeal manipulation
When the laryngeal view is insufficient during laryngoscope, another physician can manipulate the larynx externally to improve the laryngeal view. The necessity of external laryngeal manipulation will be recorded.
Measured: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
magill forceps
when the nasotracheal tube can not introduced to vocal cord manually, magill forceps can hold the tube to advance the tube through vocal cord. The necessity of magill forceps during intubation will be recorded
Measured: when laryngoscope is appropriately placed during intubation, approximately 5 seconds
IDS (intubation difficulty scale)
IDS score is the sum of the following seven variables:
N1: the number of intubation attempts>1 N2: the number of operators. 1 N3: the number of alternative intubation techniques used N4: glottic exposure (Cormack Lehane grade minus 1) N5: Lifting force required during laryngoscopy (0=normal; 1=increased) N6: necessity for external laryngeal pressure (0=not applied; 1=applied) N7: position of the vocal cords at intubation (0=abduction/ not visualized; 1=adduction)
Measured: during intubation, approximately 90 seconds
numeric rating scale for intubation
0-10 (0; no difficulty, 10: hardest)
Measured: during intubation, approximately 90 seconds
grade of bleeding
After confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation.
Grade is 4 points scale (none/trace/moderate/severe).
Measured: 10 seconds after completion of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral SurgeryStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Go Un Roh, Ajou University School of Medicine
- Investigators
- Go Un Roh, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647606
- Sponsor's protocol ID
- AJIRB-MED-DE1-15-334
- Status last verified
- Nov 2018
- First submitted
- 28 Dec 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.
PubMed 31144258
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization
- ClinicalTrials.gov ID
- NCT02647606
- Acronym / sponsor ID
- AJIRB-MED-DE1-15-334
- Conditions
- Oral Surgery, Maxillofacial Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Jan 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 is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| McGrath Group | Experimental | Procedure: MILS, Device: McGrath videolaryngoscopeMgGrath videolaryngoscope will be used for nasotracheal intubation with MILS |
| Pentax-AWS Group | Experimental | Procedure: MILS, Device: Pentax AWS videolaryngoscopePentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS |
| Macintosh Laryngoscope Group | Experimental | Procedure: MILS, Device: Macintosh laryngoscopeMacintosh Laryngoscope will be used for nasotracheal intubation with MILS |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- oral or maxillofacial surgery
- ASA class I, II
Key exclusion criteria (4 listed)
- anticipated difficult intubation
- necessity for rapid sequence induction
- cervical spine injury
- 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 |
|---|---|---|
| MILSMILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway. | Procedure or surgery | Macintosh Laryngoscope Group, McGrath Group, Pentax-AWS Group |
| McGrath videolaryngoscopeMcGrath videolaryngoscope will be used for intubation | Device | McGrath Group |
| Pentax AWS videolaryngoscopePentax AWS videolaryngoscope will be used for intubation | Device | Pentax-AWS Group |
| Macintosh laryngoscopeMacintosh laryngoscope will be used for intubation | Device | Macintosh Laryngoscope Group |
Primary outcome
time for intubation
Time frame: from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
Cormack Lehane Laryngeal view
Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
POGP score
Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
Percentage of glottic opening(POGO)
5 secondary outcomes
external laryngeal manipulation
Time frame: when laryngoscope is appropriately placed during intubation, approximately 2 seconds
magill forceps
Time frame: when laryngoscope is appropriately placed during intubation, approximately 5 seconds
IDS (intubation difficulty scale)
Time frame: during intubation, approximately 90 seconds
numeric rating scale for intubation
Time frame: during intubation, approximately 90 seconds
grade of bleeding
Time frame: 10 seconds after completion of 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 6 Nov 2018.
- Derived from this study: PubMed 31144258Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.
- 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.
Go Un Roh, MD principal investigator
Ajou University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing MILS, McGrath videolaryngoscope and Pentax AWS videolaryngoscope in people with Oral Surgery and Maxillofacial Surgery, run by Ajou University School of Medicine.
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 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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 for intubation (time frame: from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds). The study lists 3 primary outcomes in all. 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 NCT02647606, which also lists 1 linked publication.
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 6 Nov 2018.