Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation

September 15, 2022 updated by: Han-Liang Chiang, Kaohsiung Veterans General Hospital.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
247

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813414
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Video laryngoscope with Miller approach
Miller approach indicates lifting epiglottis during laryngoscopy, which is the way of using Miller laryngoscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Veterans General Hospital.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: HAN-LIANG JIANG, MD, Kaohsiung Veterans General Hospital, Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VGHKS19-CT9-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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