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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05545982
Other study ID # VGHKS19-CT9-11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2019
Est. completion date November 22, 2021

Study information

Verified date September 2022
Source Kaohsiung Veterans General Hospital.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 247
Est. completion date November 22, 2021
Est. primary completion date November 22, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Aged>20 2. Scheduled to received operation that required general anesthesia with endotracheal tube [3] ASA I, II Exclusion Criteria: 1. Emergent surgery 2. pregnant 3. Limited mouth opening 4. Poor dental condition 5. Airway obstruction (oral tumor, hypopharyngeal cancer….etc) 6. Deep neck infection 7. Allergic to any anesthetic

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Video laryngoscope with Miller approach
Miller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope

Locations

Country Name City State
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Serocki G, Bein B, Scholz J, Dörges 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Post intubation adverse event Some adverse events are often seen after intubation, such as sore throat, hoarseness....etc. Visit the patient daily at post operation day 1 and record any adverse event until post operation day3 or the patient is discharged.
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