Intratracheal Intubation in Critical CareMACMANNCT02413723
McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit
A study testing Videolaryngoscope and Standard laryngoscope in people with Intratracheal Intubation in Critical Care, run by Centre Hospitalier Departemental Vendee at 7 sites in France.
Trial summary
The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intratracheal Intubation in Critical Care
- What is being tested?
- Videolaryngoscope and Standard laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 371 participants
- Where
- 7 sitesFrance
- Study dates
- May 2015to Feb 2016
- 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
- Requiring orotracheal intubation
Who cannot join
- Contraindication to orotracheal intubation
- Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)
- Minor (<18 )
- Pregnant, parturient , or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
- Patient under guardianship or curators
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- Lack of social insurance
- Lack of informed consent
- Concomitant inclusion in a trial whose primary endpoint focuses on intubation procedure
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Louis Mourier
Colombes, 92701
CHD Vendee
La Roche-sur-Yon
CHU Orleans
Orléans
CHU Saint Louis
Paris, 75010
CHU Paris Cochin
Paris, 75014
CHU Strasbourg Nouvel Hôpital Civil
Strasbourg
CHU Tours
Tours
About this study
The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.
- Being tested
- Videolaryngoscope, Standard laryngoscope
- Keywords
- intubation, critical care, laryngoscope, videolaryngoscope, intratracheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideolaryngoscopeDevice
Also called Mc Grath videolaryngoscope
McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.
Standard laryngoscopeDevice
Also called Macintosh laryngoscope
Macintosh laryngoscope will be use for first attempt of intratracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscope McGrath Mac | Active comparator | McGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation Receives: Device: Videolaryngoscope |
| Standard laryngoscope | Placebo comparator | Macintosh laryngoscope will be used for laryngoscopy for patient's intubation Receives: Device: Standard laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of successful orotracheal intubation at first laryngoscopy
Number of successful intubation at first laryngoscopy in one arm/number of included patients in the same arm.
Measured: intubation procedure, an expected average of 15 minutes
Secondary outcomes (2)
Proportion of successful orotracheal intubation all laryngoscopies pooled
Measured: intubation procedure, an expected average of 15 minutes
Time to successful orotracheal intubation
Defined by the time between the beginning of induction (injection of anesthetic drugs) and the time of confirmation of the intratracheal nature of the endotracheal tube (defined as apparition of first inflexion on the expired carbon dioxide curve)
Measured: intubation procedure, an expected average of 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionFeb 2016
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 Intratracheal Intubation in Critical CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Jean Baptiste Lascarrou, MD, Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413723
- Sponsor's protocol ID
- 2014-A00674-43
- Acronym
- MACMAN
- Status last verified
- Nov 2025
- First submitted
- 28 Mar 2015
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lascarrou JB, Le Thuaut A, Reignier J. Intubation With Video Laryngoscopy vs Direct Laryngoscopy-Reply. JAMA. 2017 May 23;317(20):2131-2132. doi: 10.1001/jama.2017.4486. No abstract available.
PubMed 28535229Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.
PubMed 26700287Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.
PubMed 28118659
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit
- ClinicalTrials.gov ID
- NCT02413723
- Acronym / sponsor ID
- MACMAN / 2014-A00674-43
- Keywords
- intubation, critical care, laryngoscope, videolaryngoscope, intratracheal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Apr 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.
The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscope McGrath Mac | Active comparator | Device: VideolaryngoscopeMcGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation |
| Standard laryngoscope | Placebo comparator | Device: Standard laryngoscopeMacintosh laryngoscope will be used for laryngoscopy for patient's intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Requiring orotracheal intubation
Key exclusion criteria (9 listed)
- Contraindication to orotracheal intubation
- Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)
- Minor (<18 )
- Pregnant, parturient , or breast-feeding woman
- Patient hospitalized without consent and/or deprived of liberty by court's decision
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 |
|---|---|---|
| VideolaryngoscopeAlso: Mc Grath videolaryngoscopeMcGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation. | Device | Videolaryngoscope McGrath Mac |
| Standard laryngoscopeAlso: Macintosh laryngoscopeMacintosh laryngoscope will be use for first attempt of intratracheal intubation. | Device | Standard laryngoscope |
Primary outcome
Proportion of successful orotracheal intubation at first laryngoscopy
Time frame: intubation procedure, an expected average of 15 minutes
Number of successful intubation at first laryngoscopy in one arm/number of included patients in the same arm.
2 secondary outcomes
Proportion of successful orotracheal intubation all laryngoscopies pooled
Time frame: intubation procedure, an expected average of 15 minutes
Time to successful orotracheal intubation
Time frame: intubation procedure, an expected average of 15 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 17 Nov 2025.
- Background: PubMed 28535229Lascarrou JB, Le Thuaut A, Reignier J. Intubation With Video Laryngoscopy vs Direct Laryngoscopy-Reply. JAMA. 2017 May 23;317(20):2131-2132. doi: 10.1001/jama.2017.4486. No abstract available.
- Background: PubMed 26700287Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.
- Results publication: PubMed 28118659Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.
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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.
Jean Baptiste Lascarrou, MD principal investigator
CHD Vendee
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videolaryngoscope and Standard laryngoscope in people with Intratracheal Intubation in Critical Care, run by Centre Hospitalier Departemental Vendee at 7 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 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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?
Proportion of successful orotracheal intubation at first laryngoscopy (time frame: intubation procedure, an expected average of 15 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 NCT02413723, 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 17 Nov 2025.