Airway MorbidityEMMANCT02611986
Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study)
A study testing the McGrath MAC and the Macintosh Laryngoscope in people with Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- the McGrath MAC and the Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,466 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2015to 14 May 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
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- ASA classification> 3
- situations where the possibility of accumulated gastric contents
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.
Read the detailed description
As airway management continues to evolve the investigators do not have an accurate statement of the success of direct laryngoscopy in daily clinical practice. The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to direct laryngoscopy. An international, multi-center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.
- Conditions
- Airway Morbidity
- Being tested
- the McGrath MAC, the Macintosh Laryngoscope
- Keywords
- Airway management, video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the McGrath MACDevice
in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
the Macintosh LaryngoscopeDevice
in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
| Study group | Role | What they receive |
|---|---|---|
| McGrath MAC | Experimental | tracheal intubation using the McGrath MAC Receives: Device: the McGrath MAC |
| Macintosh Laryngoscope | Experimental | tracheal intubation using the Macintosh Laryngoscope Receives: Device: the Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation success
successful tracheal intubation at the first attempt, compared to more than one attempt
Measured: at intubation; < 120 seconds
Secondary outcomes (4)
Cormack and Lehane Classification
after insert the instrument the user describe the view of the laryngeal structure
Measured: < 120 seconds
Percentage of glottic opening
airway visualization during intubation process
Measured: < 120 seconds
Number of attempts
after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)
Measured: < 120 seconds
IDS (intubation difficult score)
intubation difficult score
Measured: < 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2015 (estimated)
- Study start11 Nov 2015
- Primary completion7 May 2019
- Study completion14 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Western University, Canada, Mutterhaus der Borromäerinnen, Germany, Christophorus Hospital, Germany
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University JG, MainzRüdiger Noppens, MD,Phd, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611986
- Sponsor's protocol ID
- JohannesGUE
- Acronym
- EMMA
- Status last verified
- May 2019
- First submitted
- 15 Nov 2015
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
PubMed 26336853Alvis BD, Hester D, Watson D, Higgins M, St Jacques P. Randomized controlled trial comparing the McGrath MAC video laryngoscope with the King Vision video laryngoscope in adult patients. Minerva Anestesiol. 2016 Jan;82(1):30-5. Epub 2015 Apr 17.
PubMed 25881731Kriege M, Alflen C, Tzanova I, Schmidtmann I, Piepho T, Noppens RR. Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol. BMJ Open. 2017 Aug 21;7(8):e016907. doi: 10.1136/bmjopen-2017-016907.
PubMed 28827261
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Video Laryngoscopy (Video Macintosh-blade) and Direct Laryngoscopy (EMMA-Study): A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT02611986
- Acronym / sponsor ID
- EMMA / JohannesGUE
- Conditions
- Airway Morbidity
- Keywords
- Airway management, video laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,466 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Western University, Canada, Mutterhaus der Borromäerinnen, Germany, Christophorus Hospital, Germany
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 14 May 2019 (actual)
- First posted
- 23 Nov 2015 (estimated)
- 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.
A randomized controlled prospective study of laryngoscopy and intubation success comparing direct laryngoscopy and the McGrath® Mac videolaryngoscope.
Detailed description
As airway management continues to evolve the investigators do not have an accurate statement of the success of direct laryngoscopy in daily clinical practice. The use of videolaryngoscopy is increasing as a technique for rescue intubation as well as for elective intubation. Current airway management guidelines recommend video-assisted laryngoscopy as a choice for basic airway management. This is a proposed comparison study of a video laryngoscope, use in the daily anesthesia practice, and its likely increased success compared to direct laryngoscopy. An international, multi-center, prospective randomized comparative trial (RCT) is proposed testing the superiority of oral tracheal intubation with the McGrath® MAC versus conventional laryngoscope in adult patients under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McGrath MAC | Experimental | Device: the McGrath MACtracheal intubation using the McGrath MAC |
| Macintosh Laryngoscope | Experimental | Device: the Macintosh Laryngoscopetracheal intubation using the Macintosh Laryngoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
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 |
|---|---|---|
| the McGrath MACin a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea. | Device | McGrath MAC |
| the Macintosh Laryngoscopein a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea. | Device | Macintosh Laryngoscope |
Primary outcome
intubation success
Time frame: at intubation; < 120 seconds
successful tracheal intubation at the first attempt, compared to more than one attempt
4 secondary outcomes
Cormack and Lehane Classification
Time frame: < 120 seconds
Percentage of glottic opening
Time frame: < 120 seconds
Number of attempts
Time frame: < 120 seconds
IDS (intubation difficult score)
Time frame: < 120 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Background: PubMed 26336853Wallace CD, Foulds LT, McLeod GA, Younger RA, McGuire BE. A comparison of the ease of tracheal intubation using a McGrath MAC((R)) laryngoscope and a standard Macintosh laryngoscope. Anaesthesia. 2015 Nov;70(11):1281-5. doi: 10.1111/anae.13209. Epub 2015 Sep 4.
- Background: PubMed 25881731Alvis BD, Hester D, Watson D, Higgins M, St Jacques P. Randomized controlled trial comparing the McGrath MAC video laryngoscope with the King Vision video laryngoscope in adult patients. Minerva Anestesiol. 2016 Jan;82(1):30-5. Epub 2015 Apr 17.
- Derived from this study: PubMed 28827261Kriege M, Alflen C, Tzanova I, Schmidtmann I, Piepho T, Noppens RR. Evaluation of the McGrath MAC and Macintosh laryngoscope for tracheal intubation in 2000 patients undergoing general anaesthesia: the randomised multicentre EMMA trial study protocol. BMJ Open. 2017 Aug 21;7(8):e016907. doi: 10.1136/bmjopen-2017-016907.
- Individual participant dataSharing planned: No
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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.
Marc Kriege, MD principal investigator
University JG, Mainz
Rüdiger Noppens, MD,Phd principal investigator
Western 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 the McGrath MAC and the Macintosh Laryngoscope in people with Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 15 May 2019. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intubation success (time frame: at intubation; < 120 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611986, which also lists 3 linked publications.
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 15 May 2019.