IntubationNCT03503279
Endotracheal Tube Placement Using McGrath MAC® Video Laryngoscope Versus Macintosh Laryngoscope
A study testing McGrath MAC® Video Laryngoscope in people with Intubation, run by Ohio State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- McGrath MAC® Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
2.2. Inclusion Criteria
- Patients (male or female) admitted for elective bariatric surgery under general anesthesia with orotracheal intubation
- Age > 18 years old
- American Society of Anesthesiologists (ASA) score 1-3
- Patients capable of consenting in English language
2.3. Exclusion Criteria
- Potential or history of difficult airway (see pages 11 and 12)
- 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
- 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
- Pregnant women
- Prisoners
- Surgery requiring patient positioning other than supine
- Other mental, physical, and medical conditions where subject participation is inadvisable according to the investigator judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Intubation
- Being tested
- McGrath MAC® Video Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGrath MAC® Video LaryngoscopeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Macintosh Laryngoscope | No intervention | Not described |
| McGrath MAC® Video Laryngoscope | Active comparator | Not described Receives: Device: McGrath MAC® Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Through study completion, on average of 1 week
Secondary outcomes (5)
Difference in hemodynamic stimulation (airway manipulation) events in both groupsmanipulation in both groups
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).
Measured: within 5 minutes after orotracheal intubation
Overall difference of the duration (seconds) of ETT placement between both groups
- 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.
Measured: 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.
Difference of the duration (seconds) of ETT placement
Measured: 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
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
Measured: Baseline (Preoperative)
Number of intubation attempts between both groups
Number of intubation attempts
Measured: Procedure (Time starting at first attempt to successful attempt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Jan 2021 (estimated)
- Primary completion2 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Why it stopped: Study was never started. PI left our institution and no other PI was identified
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Fiorda, Ohio State University
- Investigators
- Sergio Bergese, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503279
- Sponsor's protocol ID
- 2017H0236
- Status last verified
- May 2020
- First submitted
- 22 Mar 2018
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Center Study to Compare Endotracheal Tube Placement Using McGrath MAC® Video Laryngoscope Versus Macintosh Laryngoscope in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03503279
- Acronym / sponsor ID
- 2017H0236
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started. PI left our institution and no other PI was identified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 2 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh Laryngoscope | No intervention | – |
| McGrath MAC® Video Laryngoscope | Active comparator | Device: McGrath MAC® Video Laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McGrath MAC® Video LaryngoscopeMcGrath 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 | Device | McGrath MAC® Video Laryngoscope |
Primary outcome
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.
5 secondary outcomes
Difference in hemodynamic stimulation (airway manipulation) events in both groupsmanipulation in both groups
Time frame: 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
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 STOP BANG score between both groups
Time frame: Baseline (Preoperative)
Number of intubation attempts between both groups
Time frame: Procedure (Time starting at first attempt to successful attempt)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Bergese principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGrath MAC® Video Laryngoscope in people with Intubation, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.