- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05545982
Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kaohsiung, Taiwan, 813414
- Kaohsiung Veterans General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged>20
- Scheduled to received operation that required general anesthesia with endotracheal tube [3] ASA I, II
Exclusion Criteria:
- Emergent surgery
- pregnant
- Limited mouth opening
- Poor dental condition
- Airway obstruction (oral tumor, hypopharyngeal cancer….etc)
- Deep neck infection
- Allergic to any anesthetic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intubation with Miller approach
Posttest group: Patient receive intubation with conventional video laryngoscope with Miller approach. Pretest group: Patient receive intubation with conventional video laryngoscope with Macintosh approach. |
Miller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Some adverse events are often seen after intubation, such as sore throat, hoarseness....etc.
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Visit the patient daily at post operation day 1 and record any adverse event until post operation day3 or the patient is discharged.
|
Collaborators and Investigators
Investigators
- Study Chair: HAN-LIANG JIANG, MD, Kaohsiung Veterans General Hospital, Department of Anesthesiology
Publications and helpful links
General 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.
- Kido 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.
- El-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.
- Aziz 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.
- Liu 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.
- Huang P, Zhou R, Lu Z, Hang Y, Wang S, Huang Z. GlideScope® versus C-MAC®(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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- VGHKS19-CT9-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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