NCT05545982

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 7, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

difficult intubationvideo laryngoscope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post intubation adverse event

    Visit the patient daily at post operation day 1 and record any adverse event until post operation day3 or the patient is discharged.

Study Arms (1)

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.

Procedure: Video laryngoscope with Miller approach

Interventions

Miller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope

Intubation with Miller approach

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged\>20
  • Scheduled to received operation that required general anesthesia with endotracheal tube \[3\] ASA I, II

You may not qualify if:

  • Emergent surgery
  • pregnant
  • Limited mouth opening
  • Poor dental condition
  • Airway obstruction (oral tumor, hypopharyngeal cancer….etc)
  • Deep neck infection
  • Allergic to any anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813414, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 19809328BACKGROUND
  • 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.

    PMID: 26111665BACKGROUND
  • 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.

    PMID: 29056498BACKGROUND
  • 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.

    PMID: 26579847BACKGROUND
  • 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.

    PMID: 31092191BACKGROUND
  • Huang 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.

    PMID: 32434470BACKGROUND

Study Officials

  • HAN-LIANG JIANG, MD

    Kaohsiung Veterans General Hospital, Department of Anesthesiology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one-group pretest-posttest study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiothoracic Anesthesiology

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 19, 2022

Study Start

October 4, 2019

Primary Completion

November 22, 2021

Study Completion

November 22, 2021

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

We had no experience of making IPD. If it's helpful to other researcher, then we'll try figure out how to do it.

Locations