Endotracheal Tube Placement Using McGrath MAC® Video Laryngoscope Versus Macintosh Laryngoscope

May 28, 2020 updated by: Juan Fiorda, Ohio State University

A Prospective, Randomized, Single Center Study to Compare Endotracheal Tube Placement Using McGrath MAC® Video Laryngoscope Versus Macintosh Laryngoscope in Bariatric Surgery Patients

This study aims...

  • To assess the difference in intubation difficulty scale (IDS) score following ETT placement using McGrath MAC® video laryngoscope versus conventional intubation with Macintosh laryngoscope for bariatric surgery patients
  • To assess the difference in hemodynamic stimulation (airway manipulation) events in both groups
  • To assess the overall difference of the duration (seconds) of ETT placement between both groups
  • To assess the difference of the duration (seconds) of ETT placement during every attempt (maximum of three attempts) between both groups.
  • To assess the difference of STOP BANG score between both groups
  • To assess the number of intubation attempts between both groups

Study Overview

Status

Status

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Withdrawn

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

The failure to place properly an endotracheal tube (ETT) and to secure the airway is still significantly impacting morbidity and mortality in surgical and critical care settings. In addition, no assertive predictor factor will foresee the presence of difficult airway, most of them being acknowledged after anesthesia induction. The incidence of difficult intubation reported in different studies varies from 0.1% to 13%.

The gold standard device to place an ETT that has been used since 1943 is the Macintosh laryngoscope (ML). However, in contemplation of addressing these challenging factors related to endotracheal intubation failure, modern airway devices technology has been developed in order to improve orotracheal visualization, reduce orotracehal manipulation and ensure airway patency.

As part of these novel devices, several video laryngoscopies (VL) have s been developed to secure the airway and improve the management of difficult intubation. Difficult Airway Society (DAS) guidelines recognizes the usefulness of VL in difficult intubation by providing an improved view of the airway to clinicians and directly observe/report the effects of laryngeal manipulation.

Among several VL introduced recently, a McGrath MAC® VL was announced in 2012. McGrath MAC® is a self-contained VL with a single-use blade; its structure is similar to the ML, but without the channel that guides the tube and a mounted LCD screen on the handle that is connected to a miniature camera with a light source at the tip of the blade, allowing the clinicians to directly observe surrounding anatomical airway structures during a tracheal intubation. These features have shown a better glottis visualization and to be supportive during tracheal intubation of difficult airways.

The McGrath MAC® VL and ML are standard of care devices used according to anesthesia care providers' criteria at our institution.

A single-center, prospective, randomized, double arm study, will be conducted in order to test the following hypothesis:

Reduced manipulation of the airway using McGrath MAC® VL will lead to less hemodynamic stimulation events following intubation when compared to ML.

The non-disposable portion of the McGrath MAC® VL (upper mounted reusable video camera and the optic guide) will be cleaned between usages in accordance to manufacture catalogue and institutional policy (using disinfectants such as CIDEXTM OPA, a 0.08% paracetic acid solution or disinfecting wipes).

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

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

2.2. Inclusion Criteria

  1. Patients (male or female) admitted for elective bariatric surgery under general anesthesia with orotracheal intubation
  2. Age > 18 years old
  3. American Society of Anesthesiologists (ASA) score 1-3
  4. Patients capable of consenting in English language

2.3. Exclusion Criteria

  1. Potential or history of difficult airway (see pages 11 and 12)
  2. Past medical history of confirmed uncontrolled gastrointestinal diseases including delayed gastric emptying, dysphagia, or other gastrointestinal motility disorders that according to the investigator will not qualify for the study
  3. Patients with uncontrolled metabolic disorders (e.g., diabetes mellitus, chronic kidney disease) or conditions that according to the investigator will not qualify for the study
  4. Pregnant women
  5. Prisoners
  6. Surgery requiring patient positioning other than supine
  7. Other mental, physical, and medical conditions where subject participation is inadvisable according to the investigator judgment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
No Intervention: Macintosh Laryngoscope
Active Comparator: McGrath MAC® Video Laryngoscope
Device: McGrath MAC® Video Laryngoscope
McGrath MAC® Video Laryngoscope have been developed to secure the airway and improve the management of difficult intubation. McGrath MAC® is a self-contained VL with a single-use blade; its structure is similar to the ML, but without the channel that guides the tube and a mounted LCD screen on the handle that is connected to a miniature camera with a light source at the tip of the blade, allowing the clinicians to directly observe surrounding anatomical airway structures during a tracheal intubation

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
Difference in intubation difficulty scale (IDS) score following ETT placement using McGrath MAC® video laryngoscope versus conventional intubation with Macintosh laryngoscope for bariatric surgery patients
Time Frame: Through study completion, on average of 1 week
The Intubation Difficulty Scale (IDS) is a mixture of subjective and objective conditions that allows a qualitative and quantitative methodology to the progressive nature of the difficulty of intubation (easy=0, slightly difficult= 0<IDS≤5, moderate to major difficult= 5<IDS, impossible intubation= ∞). It could be used to asses intubating conditions and methods with the objective of determining the relative values predictive factors of intubation difficulty and of the techniques used to decrease such difficulties. It has seven parameters that are scored after an intubation: # of intubation attempts; # of alternative techniques used; a modified Cormack grade for glottic visualization; subjective impression of the lifting force needed during laryngoscopy; the need for external laryngeal pressure to optimize glottic exposure; and the position of the vocal cords.
Through study completion, on average of 1 week

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
Difference in hemodynamic stimulation (airway manipulation) events in both groupsmanipulation in both groups
Time Frame: within 5 minutes after orotracheal intubation

Hemodynamic events are defined as:

  • Significant variation in heart rate (HR) (defined as an increase/ decrease in HR greater than 20% of the baseline HR levels during airway management, within 5 minutes after orotracheal intubation) and,
  • Significant variations in mean blood pressure (MBP) (defined as an increase/ decrease in MBP greater than 20% of the baseline MBP levels during airway management, within 5 minutes after orotracheal intubation).
within 5 minutes after orotracheal intubation
Overall difference of the duration (seconds) of ETT placement between both groups
Time Frame: The length of time between the date and time when the start of endotracheal tube descent maneuver until the date and time when the tube is considered well positioned in the trachea, assessed up to 10 minutes
• The duration of intubation is defined as the time taken from the insertion of the blade beyond the incisors until the verification of the presence of three consecutive normal capnography wave forms.
The length of time between the date and time when the start of endotracheal tube descent maneuver until the date and time when the tube is considered well positioned in the trachea, assessed up to 10 minutes
Difference of the duration (seconds) of ETT placement during every attempt (maximum of three attempts) between both groups.
Time Frame: Procedure (The duration of intubation is defined as the time taken from the insertion of the blade beyond the incisors until the verification of the presence of three consecutive normal capnography wave forms.)
Difference of the duration (seconds) of ETT placement
Procedure (The duration of intubation is defined as the time taken from the insertion of the blade beyond the incisors until the verification of the presence of three consecutive normal capnography wave forms.)
Difference of STOP BANG score between both groups
Time Frame: Baseline (Preoperative)

Do you SNORE loudly (louder than talking or loud enough to be heard through closed doors)? Yes = 1 No = 0 Do you often feel TIRED, fatigued, or sleepy during daytime? Yes = 1 No = 0 Has anyone OBSERVED you stop breathing during your sleep? Yes = 1 No = 0 Do you have or are you being treated for high blood PRESSURE? Yes = 1 No = 0

BANG BMI more than 35kg/m2? Yes = 1 No = 0 AGE over 50 years old? Yes = 1 No = 0 NECK circumference > 16 inches (40cm)? Yes = 1 No = 0 GENDER: Male? Yes = 1 No = 0
Baseline (Preoperative)
Number of intubation attempts between both groups
Time Frame: Procedure (Time starting at first attempt to successful attempt)
Number of intubation attempts
Procedure (Time starting at first attempt to successful attempt)

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.
Ohio State University

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.
  • Principal Investigator: Sergio Bergese, The Ohio State University Wexner Medical Center

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 (Anticipated)

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.
January 1, 2021

Primary Completion (Anticipated)

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.
February 2, 2021

Study Completion (Anticipated)

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.
March 1, 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).
March 22, 2018

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.
April 18, 2018

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.
April 19, 2018

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.
June 1, 2020

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.
May 28, 2020

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.
May 1, 2020

More Information

Terms related to this study

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.
  • 2017H0236

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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