Difficult IntubationNCT05545982
Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation
A study testing Video laryngoscope with Miller approach in people with Difficult Intubation, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Video laryngoscope has become recommended option during difficult intubation. Guidelines of ASA at 2013 had suggested using video laryngoscope after failure intubation of direct laryngoscope. Varieties of video laryngoscope had been invented with different curves. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- Video laryngoscope with Miller approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Oct 2019to 22 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged>20
- Scheduled to received operation that required general anesthesia with endotracheal tube [3] ASA I, II
Who cannot join
- Emergent surgery
- pregnant
- Limited mouth opening
- Poor dental condition
- Airway obstruction (oral tumor, hypopharyngeal cancer….etc)
- Deep neck infection
- Allergic to any anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Video laryngoscope has become recommended option during difficult intubation. Guidelines of ASA at 2013 had suggested using video laryngoscope after failure intubation of direct laryngoscope. Varieties of video laryngoscope had been invented with different curves. We call the one which has the same curve of Macintosh laryngoscope as conventional video laryngoscope in this study. Mostly, the way of using conventional video laryngoscope is suggested as Macintosh method. However, with the front positioning camera, Miller method can theoretically improve the glottic opening. We intend to discuss whether using Miller approach with conventional video laryngoscope can improve glottic opening or not.
Read the detailed description
Video scope can provide better glottic opening by increase the tilting angle of the tip, and the position of camera can provide larger vision angle. However, while the angle increases, the endotracheal tube must fallow the curve, which may require learning curve of the operator. In Glidescope as example, increase the tilting angle can help with glottic exposure, however the steep curve will simultaneously increase the difficulty of inserting the tube or using Magill forceps, especially while intubating double lumen or nasal endotracheal tube. Conventional video laryngoscope in this study indicates the video laryngoscope blade which has the same curve as Macintosh laryngoscope. It mainly improves the glottic view by front positioning camera.
Anesthesiologist usually place the tip of the blade at vallecula to expose the glottic which is the conventional ways of using Macintosh blade which we name it as Macintosh method. Placing the tip below the epiglottis and lift it up directly is the way of using Miller blade. Theoretically, the Miller method with conventional video laryngoscope may improve the scale of glottic exposure measured with Cormack-Lehane grade. This is a one-group pretest-posttest study to compare the Cormack-Lehane grade with two different methods in the same patient. This study tends to discuss whether this combination can improve the glottic exposure and preserve the advantage of direct laryngoscope.
- Conditions
- Difficult Intubation
- Being tested
- Video laryngoscope with Miller approach
- Keywords
- difficult intubation, video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video laryngoscope with Miller approachProcedure or surgery
Miller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Intubation with Miller approach | Experimental | Posttest group: Patient receive intubation with conventional video laryngoscope with Miller approach.
Pretest group: Patient receive intubation with conventional video laryngoscope with Macintosh approach. Receives: Procedure: Video laryngoscope with Miller approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cormack lehane grade
Compare the difference of cormack lehane grade using Macintosh ot Miller approach.(cormack lehane grade has four gradings. Grade 1 represent entire glottic opening. Grade 4 represent vocal cord cab not be seen)
Measured: Measured from glottic exposed by Macintosh approach to Miller approach. Record the cormack lehane grade. The whole precess will be completed within 5 minutes if there are no difficult intubation.
Secondary outcomes (1)
Post intubation adverse event
Some adverse events are often seen after intubation, such as sore throat, hoarseness....etc.
Measured: Visit the patient daily at post operation day 1 and record any adverse event until post operation day3 or the patient is discharged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start4 Oct 2019
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Difficult 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- one-group pretest-posttest study
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Liang Chiang, Kaohsiung Veterans General Hospital.
- Investigators
- HAN-LIANG JIANG, MD, Study chair, Kaohsiung Veterans General Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545982
- Sponsor's protocol ID
- VGHKS19-CT9-11
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We had no experience of making IPD. If it's helpful to other researcher, then we'll try figure out how to do it.
Publications
Serocki G, Bein B, Scholz J, Dorges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b013e32832d328d.
PubMed 19809328Kido H, Komasawa N, Matsunami S, Kusaka Y, Minami T. Comparison of McGRATH MAC and Macintosh laryngoscopes for double-lumen endotracheal tube intubation by anesthesia residents: a prospective randomized clinical trial. J Clin Anesth. 2015 Sep;27(6):476-80. doi: 10.1016/j.jclinane.2015.05.011. Epub 2015 Jun 22.
PubMed 26111665El-Tahan MR, Khidr AM, Gaarour IS, Alshadwi SA, Alghamdi TM, Al'ghamdi A. A Comparison of 3 Videolaryngoscopes for Double-Lumen Tube Intubation in Humans by Users With Mixed Experience: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):277-286. doi: 10.1053/j.jvca.2017.08.009. Epub 2017 Aug 4.
PubMed 29056498Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.
PubMed 26579847Liu DX, Ye Y, Zhu YH, Li J, He HY, Dong L, Zhu ZQ. Intubation of non-difficult airways using video laryngoscope versus direct laryngoscope: a randomized, parallel-group study. BMC Anesthesiol. 2019 May 15;19(1):75. doi: 10.1186/s12871-019-0737-3.
PubMed 31092191Huang P, Zhou R, Lu Z, Hang Y, Wang S, Huang Z. GlideScope(R) versus C-MAC(R)(D) videolaryngoscope versus Macintosh laryngoscope for double lumen endotracheal intubation in patients with predicted normal airways: a randomized, controlled, prospective trial. BMC Anesthesiol. 2020 May 20;20(1):119. doi: 10.1186/s12871-020-01012-y.
PubMed 32434470
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT05545982
- Acronym / sponsor ID
- VGHKS19-CT9-11
- Conditions
- Difficult Intubation
- Keywords
- difficult intubation, video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 19 Sep 2022 (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.
Video laryngoscope has become recommended option during difficult intubation. Guidelines of ASA at 2013 had suggested using video laryngoscope after failure intubation of direct laryngoscope. Varieties of video laryngoscope had been invented with different curves. We call the one which has the same curve of Macintosh laryngoscope as conventional video laryngoscope in this study. Mostly, the way of using conventional video laryngoscope is suggested as Macintosh method. However, with the front positioning camera, Miller method can theoretically improve the glottic opening. We intend to discuss whether using Miller approach with conventional video laryngoscope can improve glottic opening or not.
Detailed description
Video scope can provide better glottic opening by increase the tilting angle of the tip, and the position of camera can provide larger vision angle. However, while the angle increases, the endotracheal tube must fallow the curve, which may require learning curve of the operator. In Glidescope as example, increase the tilting angle can help with glottic exposure, however the steep curve will simultaneously increase the difficulty of inserting the tube or using Magill forceps, especially while intubating double lumen or nasal endotracheal tube. Conventional video laryngoscope in this study indicates the video laryngoscope blade which has the same curve as Macintosh laryngoscope. It mainly improves the glottic view by front positioning camera.
Anesthesiologist usually place the tip of the blade at vallecula to expose the glottic which is the conventional ways of using Macintosh blade which we name it as Macintosh method. Placing the tip below the epiglottis and lift it up directly is the way of using Miller blade. Theoretically, the Miller method with conventional video laryngoscope may improve the scale of glottic exposure measured with Cormack-Lehane grade. This is a one-group pretest-posttest study to compare the Cormack-Lehane grade with two different methods in the same patient. This study tends to discuss whether this combination can improve the glottic exposure and preserve the advantage of direct laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- one-group pretest-posttest study
| Arm | Type | Receives |
|---|---|---|
| Intubation with Miller approach | Experimental | Procedure: Video laryngoscope with Miller approachPosttest group: Patient receive intubation with conventional video laryngoscope with Miller approach. Pretest group: Patient receive intubation with conventional video laryngoscope with Macintosh approach. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged>20
- Scheduled to received operation that required general anesthesia with endotracheal tube [3] ASA I, II
Key exclusion criteria (7 listed)
- Emergent surgery
- pregnant
- Limited mouth opening
- Poor dental condition
- Airway obstruction (oral tumor, hypopharyngeal cancer….etc)
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 |
|---|---|---|
| Video laryngoscope with Miller approachMiller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope | Procedure or surgery | Intubation with Miller approach |
Primary outcome
Change of cormack lehane grade
Time frame: Measured from glottic exposed by Macintosh approach to Miller approach. Record the cormack lehane grade. The whole precess will be completed within 5 minutes if there are no difficult intubation.
Compare the difference of cormack lehane grade using Macintosh ot Miller approach.(cormack lehane grade has four gradings. Grade 1 represent entire glottic opening. Grade 4 represent vocal cord cab not be seen)
1 secondary outcome
Post intubation adverse event
Time frame: Visit the patient daily at post operation day 1 and record any adverse event until post operation day3 or the patient is discharged.
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 Sep 2022.
- Background: PubMed 19809328Serocki G, Bein B, Scholz J, Dorges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b013e32832d328d.
- Background: PubMed 26111665Kido H, Komasawa N, Matsunami S, Kusaka Y, Minami T. Comparison of McGRATH MAC and Macintosh laryngoscopes for double-lumen endotracheal tube intubation by anesthesia residents: a prospective randomized clinical trial. J Clin Anesth. 2015 Sep;27(6):476-80. doi: 10.1016/j.jclinane.2015.05.011. Epub 2015 Jun 22.
- Background: PubMed 29056498El-Tahan MR, Khidr AM, Gaarour IS, Alshadwi SA, Alghamdi TM, Al'ghamdi A. A Comparison of 3 Videolaryngoscopes for Double-Lumen Tube Intubation in Humans by Users With Mixed Experience: A Randomized Controlled Study. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):277-286. doi: 10.1053/j.jvca.2017.08.009. Epub 2017 Aug 4.
- Background: PubMed 26579847Aziz MF, Abrons RO, Cattano D, Bayman EO, Swanson DE, Hagberg CA, Todd MM, Brambrink AM. First-Attempt Intubation Success of Video Laryngoscopy in Patients with Anticipated Difficult Direct Laryngoscopy: A Multicenter Randomized Controlled Trial Comparing the C-MAC D-Blade Versus the GlideScope in a Mixed Provider and Diverse Patient Population. Anesth Analg. 2016 Mar;122(3):740-750. doi: 10.1213/ANE.0000000000001084.
- Background: PubMed 31092191Liu DX, Ye Y, Zhu YH, Li J, He HY, Dong L, Zhu ZQ. Intubation of non-difficult airways using video laryngoscope versus direct laryngoscope: a randomized, parallel-group study. BMC Anesthesiol. 2019 May 15;19(1):75. doi: 10.1186/s12871-019-0737-3.
- Background: PubMed 32434470Huang P, Zhou R, Lu Z, Hang Y, Wang S, Huang Z. GlideScope(R) versus C-MAC(R)(D) videolaryngoscope versus Macintosh laryngoscope for double lumen endotracheal intubation in patients with predicted normal airways: a randomized, controlled, prospective trial. BMC Anesthesiol. 2020 May 20;20(1):119. doi: 10.1186/s12871-020-01012-y.
- Individual participant dataSharing planned: No. We had no experience of making IPD. If it's helpful to other researcher, then we'll try figure out how to do it.
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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.
HAN-LIANG JIANG, MD study chair
Kaohsiung Veterans General Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video laryngoscope with Miller approach in people with Difficult Intubation, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 7 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 Sep 2022. 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 Taiwan. 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?
Change of cormack lehane grade (time frame: Measured from glottic exposed by Macintosh approach to Miller approach. Record the cormack lehane grade. The whole precess will be completed within 5 minutes if there are no difficult intubation.). 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 NCT05545982, which also lists 6 linked publications.
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 Sep 2022.