LaryngoscopyMILARNCT03470116
Comparison Between the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation for Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.
A study testing Laryngoscopy with Mac Grath and direct laryngoscopy in people with Laryngoscopy, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.
Trial summary
The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Laryngoscopy
- What is being tested?
- Laryngoscopy with Mac Grath and direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,250 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Mar 2018to 23 Sep 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent
Who cannot join
- pregnancy
- age < 18
- contraindication to oro-tracheal intubation
- emergency surgery
- thoracic surgery
- naso-tracheal intubation
Show all 20Show fewer
- patient protected by law
- patient not affiliated to french social security
- BMI> 45kg / m²
- Predicted patient with difficult intubation
- Patients considered to be predisposed to difficult intubation are those with a history of difficult intubation, or with 2 criteria among:
- Mallampati 3 or 4
- Thyroid-chin distance <65mm
- Mouth opening <35mm
- Spinal extension less than 90 °
- Retrognathism with Negative Lip Test
- Morbid obesity with BMI> 35kg / m²
- Obstructive Sleep Apnea Syndrome with choker> 45cm
- Diabetic with sign of the positive prior
- Head and Neck Pathology
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chartres Hospital Center
Chartres, 28630
Orleans Hospital Center
Orléans, 45067
About this study
Official title: MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.
The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.
Read the detailed description
Tracheal intubation is a common procedure in the operating room to secure the airway in patients receiving muscle relaxants .
Two devices are currently used for this purpose with various indications: the French Society of Anesthesia and Resuscitation (SFAR) recommends a direct laryngoscopy with MacIntosh blade in first intention for patients with less than 2 criteria of difficult intubation (ID). The SFAR recommends first-line video laryngoscopy in patients with two or more criteria of difficult intubation. Video laryngoscopy improves glottic vision, difficult intubation score, and intubation success rate at the first attempt, compared to the direct laryngoscopy with a Macintosh blade.
Currently, it is estimated that 15% of direct laryngoscopies with a MacIntosh blade result in failure of orotracheal intubation (IOT) on first attempt, whereas tracheal intubation with a video laryngoscopy is a better solution to secure the airway.
Our hypothesis in this study is that the MacGrath MAC videolaryngoscope allows to intubate at the first laryngoscopy 91% of patients with less than 2 difficult intubation criteria, against the expected 85% with the MacIntosh blade.
- Conditions
- Laryngoscopy
- Being tested
- Laryngoscopy with Mac Grath, direct laryngoscopy
- Keywords
- MacGrath MAC, curarization, intubation, MacIntosh, laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscopy with Mac GrathDevice
Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
direct laryngoscopyDevice
Patients of this group will benefit direct laryngoscopy for intubation after curarization
| Study group | Role | What they receive |
|---|---|---|
| MacGrath MAC video laryngoscopy | Experimental | Patients will benefit MacGrath MAC video laryngoscopy for intubation after curarization Receives: Device: Laryngoscopy with Mac Grath |
| direct laryngoscopy | Active comparator | Patients will benefit direct laryngoscopy for intubation after curarization Receives: Device: direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful first attempt intubation after curarization
The primary endpoint is the success of tracheal intubation by anesthesiologists or registrated nurse anesthetists on exposure to first laryngoscopy, confirmed by three identical capnographic curves on the monitor.
Measured: 2 minutes
Secondary outcomes (10)
Presence of glottal exposure during the first laryngoscopy
presence or absence of glottal exposure during the first laryngoscopy
Measured: 2 minutes
Use of a second laryngoscopy
Use or not of a second laryngoscopy
Measured: 2 minutes
Type of laryngoscope used in second laryngoscopy
If second laryngoscopy is practice, name of second laryngoscope
Measured: 2 minutes
Use of a mandrel
use or not of a mandrel
Measured: 2 minutes
Use of a supra-glottal device
Use or not of a supra-glottal device
Measured: 2 minutes
Use of a fibreoptic
Use or not of a fibreoptic
Measured: 2 minutes
Use of a transtracheal oxygenation device
Use or not of a transtracheal oxygenation device
Measured: 2 minutes
Presence of desaturations <92% during laryngoscopy
presence or absence of desaturation
Measured: 2 minutes
number of esophageal intubation
Measured: 2 minutes
Pharyngeal lesions / bleeding
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start20 Mar 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LaryngoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MFAM Willy Serge, MD, Principal investigator, ORLEANS REGIONAL HOSPITAL CENTERSINDA Patrick, MD, Principal investigator, CHARTRES HOSPITAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470116
- Sponsor's protocol ID
- CHRO-2017-13
- Acronym
- MILAR
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
PubMed 21447489Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.
PubMed 22542734Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
PubMed 15271750Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.
PubMed 25996773Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.
PubMed 26725922Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German.
PubMed 26174747
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.
- ClinicalTrials.gov ID
- NCT03470116
- Acronym / sponsor ID
- MILAR / CHRO-2017-13
- Conditions
- Laryngoscopy
- Keywords
- MacGrath MAC, curarization, intubation, MacIntosh, laryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,250 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 19 Mar 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.
The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.
Detailed description
Tracheal intubation is a common procedure in the operating room to secure the airway in patients receiving muscle relaxants .
Two devices are currently used for this purpose with various indications: the French Society of Anesthesia and Resuscitation (SFAR) recommends a direct laryngoscopy with MacIntosh blade in first intention for patients with less than 2 criteria of difficult intubation (ID). The SFAR recommends first-line video laryngoscopy in patients with two or more criteria of difficult intubation. Video laryngoscopy improves glottic vision, difficult intubation score, and intubation success rate at the first attempt, compared to the direct laryngoscopy with a Macintosh blade.
Currently, it is estimated that 15% of direct laryngoscopies with a MacIntosh blade result in failure of orotracheal intubation (IOT) on first attempt, whereas tracheal intubation with a video laryngoscopy is a better solution to secure the airway.
Our hypothesis in this study is that the MacGrath MAC videolaryngoscope allows to intubate at the first laryngoscopy 91% of patients with less than 2 difficult intubation criteria, against the expected 85% with the MacIntosh blade.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MacGrath MAC video laryngoscopy | Experimental | Device: Laryngoscopy with Mac GrathPatients will benefit MacGrath MAC video laryngoscopy for intubation after curarization |
| direct laryngoscopy | Active comparator | Device: direct laryngoscopyPatients will benefit direct laryngoscopy for intubation after curarization |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- less than 2 criteria of difficult intubation admitted to the operating theater for scheduled surgery requiring orotracheal intubation after curarization - informed consent
Key exclusion criteria (20 listed)
- pregnancy
- age < 18
- contraindication to oro-tracheal intubation
- emergency surgery
- thoracic surgery
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 |
|---|---|---|
| Laryngoscopy with Mac GrathPatients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization | Device | MacGrath MAC video laryngoscopy |
| direct laryngoscopyPatients of this group will benefit direct laryngoscopy for intubation after curarization | Device | direct laryngoscopy |
Primary outcome
Successful first attempt intubation after curarization
Time frame: 2 minutes
The primary endpoint is the success of tracheal intubation by anesthesiologists or registrated nurse anesthetists on exposure to first laryngoscopy, confirmed by three identical capnographic curves on the monitor.
10 secondary outcomes
Presence of glottal exposure during the first laryngoscopy
Time frame: 2 minutes
Use of a second laryngoscopy
Time frame: 2 minutes
Type of laryngoscope used in second laryngoscopy
Time frame: 2 minutes
Use of a mandrel
Time frame: 2 minutes
Use of a supra-glottal device
Time frame: 2 minutes
Use of a fibreoptic
Time frame: 2 minutes
Use of a transtracheal oxygenation device
Time frame: 2 minutes
Presence of desaturations <92% during laryngoscopy
Time frame: 2 minutes
number of esophageal intubation
Time frame: 2 minutes
Pharyngeal lesions / bleeding
Time frame: 2 minutes
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 25 Mar 2020.
- Background: PubMed 21447489Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
- Background: PubMed 22542734Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.
- Background: PubMed 15271750Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.
- Background: PubMed 25996773Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.
- Background: PubMed 26725922Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.
- Background: PubMed 26174747Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German.
- 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.
MFAM Willy Serge, MD principal investigator
ORLEANS REGIONAL HOSPITAL CENTER
SINDA Patrick, MD principal investigator
CHARTRES HOSPITAL CENTER
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscopy with Mac Grath and direct laryngoscopy in people with Laryngoscopy, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.
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 1 inclusion and 20 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Successful first attempt intubation after curarization (time frame: 2 minutes). 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 NCT03470116, which also lists 6 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 25 Mar 2020.