AnesthesiaMGM3NCT02926144
Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?
A study testing Laryngoscope with video and Laryngoscope without video in people with Anesthesia, run by Hopital Foch at 4 sites in France.
Trial summary
The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Laryngoscope with video and Laryngoscope without video
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Nov 2016to 1 Apr 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
- Aged 18 years old minimum
- Requiring general anesthesia and orotracheal intubation with a single lumen tube
- Having signed an inform consent form
- Having a telephone and agreeing to communicate their phone number
- Benefiting from a social insurance scheme or beneficiary
Who cannot join
- Pregnant or breast-feeding women
- Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
- Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
- patients requiring a rapid-sequence intubation
- patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Institut Hospitalier Franco Britannique
Levallois-Perret, 92300
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Centre Clinical
Soyaux, 16800
Hopital Foch
Suresnes, 92150
About this study
Official title: Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?
The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.
Read the detailed description
Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score <11).
General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.
- Conditions
- Anesthesia
- Being tested
- Laryngoscope with video, Laryngoscope without video
- Keywords
- Intratracheal intubation, videolaryngoscope, McGrath MAC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngoscope with videoDevice
Also called Endotracheal intubation with laryngoscope video feature
Intubation with video-laryngoscope McGrath with use of the video feature
Laryngoscope without videoDevice
Also called Intubation without the laryngoscope video feature
Endotracheal intubation with video-laryngoscope McGrath without use of the video feature
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscope with video | Experimental | Use of the video-laryngoscope McGrath Mac with use of the video feature Receives: Device: Laryngoscope with video |
| Laryngoscope without video | Active comparator | Use of the video-laryngoscope McGrath Mac without use of the video feature Receives: Device: Laryngoscope without video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available
Intubation is video and audio recorded for further analysis. The availability of the video feature of McGRATH® MAC is hidden from the recording. Only the number of people required and the intubation characteristics can be seen on the video.
Measured: 30 minutes
Secondary outcomes (10)
Cooperation between members of the anesthesiology team during intubation
Based on the video recording: Use of the Kraus Scale (based on "Kraus M, Huang C, Keltner D: Tactile Communication, Cooperation and Performance. Emotion, 2010, 10, 745-9") evaluating communication and gestures within the team
Measured: 30 minutes
Intubation difficulty Scale (IDS)
Measured: 30 minutes
Number of hands necessary for tracheal intubation
Based on the video recording: 2 hands when one person intubates by itself without any help, 3 or 4 hands when assistance is given by a second anesthesiologist. 5 to 6 hands when a third person is needed.
Measured: 30 minutes
Time to intubate
Based on the video recording: from the entrance of the blade in the patient's mouth until the presence of the first capnogram
Measured: 30 minutes
Esophageal intubation
No capnograms during mechanical ventilation once intubation is performed
Measured: 30 minutes
Intubation failure
Based on the video recording
Measured: 30 minutes
Arterial desaturation
Based on the video recording: visualisation of a pulse oximetry inferior to 92%
Measured: 30 minutes maximum
Perception of intubation difficulty by the operator
Evaluation on a scale between zero (no difficulty at all) to ten (extremely difficult)
Measured: 30 minutes
Impact of videolaryngoscopy on hemodynamic variables
Based on the video recording: Blood pressure and heart beat on monitoring before and after video laryngoscopy
Measured: 30 minutes
Evaluation of usual complications after tracheal intubation
Sore throat or voice change noticed on day 1
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start28 Nov 2016
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Belze, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926144
- Sponsor's protocol ID
- 2016/05
- Other IDs
- 2016-A00056-45
- Acronym
- MGM3
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2016
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available in the Dryad repository.
Publications
Belze O, Coppere Z, Ouattara J, Thion LA, Paqueron X, Devys JM, Ma S, Kennel T, Fischler M, Le Guen M. Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial. BMJ Open. 2022 Jan 3;12(1):e049275. doi: 10.1136/bmjopen-2021-049275.
PubMed 34980609
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?
- ClinicalTrials.gov ID
- NCT02926144
- Acronym / sponsor ID
- MGM3 / 2016/05
- Conditions
- Anesthesia
- Keywords
- Intratracheal intubation, videolaryngoscope, McGrath MAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 Oct 2016 (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 main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.
Detailed description
Videolaryngoscopes, such as McGRATH® MAC videolaryngoscope, are used to facilitate tracheal intubations. This study is designed to evaluate the proportion of cases requiring more than one member of the anesthesiology team when the video feature of McGRATH® MAC is available during laryngoscopy in a population of patients without a predicted difficult intubation (Arne's score <11).
General anesthesia from induction until tracheal intubation is recorded on a video for further analysis. Analysis includes characteristics of intubation, patient's monitoring and cooperation between anesthesiologists in two groups. In the control group, the screen of the McGRATH® MAC videolaryngoscope is hidden. In the experimental group, the McGRATH® MAC videolaryngoscope is used with its video feature.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscope with video | Experimental | Device: Laryngoscope with videoUse of the video-laryngoscope McGrath Mac with use of the video feature |
| Laryngoscope without video | Active comparator | Device: Laryngoscope without videoUse of the video-laryngoscope McGrath Mac without use of the video feature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years old minimum
- Requiring general anesthesia and orotracheal intubation with a single lumen tube
- Having signed an inform consent form
- Having a telephone and agreeing to communicate their phone number
- Benefiting from a social insurance scheme or beneficiary
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women
- Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
- Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
- patients requiring a rapid-sequence intubation
- patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.
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 |
|---|---|---|
| Laryngoscope with videoAlso: Endotracheal intubation with laryngoscope video featureIntubation with video-laryngoscope McGrath with use of the video feature | Device | Laryngoscope with video |
| Laryngoscope without videoAlso: Intubation without the laryngoscope video featureEndotracheal intubation with video-laryngoscope McGrath without use of the video feature | Device | Laryngoscope without video |
Primary outcome
Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available
Time frame: 30 minutes
Intubation is video and audio recorded for further analysis. The availability of the video feature of McGRATH® MAC is hidden from the recording. Only the number of people required and the intubation characteristics can be seen on the video.
10 secondary outcomes
Cooperation between members of the anesthesiology team during intubation
Time frame: 30 minutes
Intubation difficulty Scale (IDS)
Time frame: 30 minutes
Number of hands necessary for tracheal intubation
Time frame: 30 minutes
Time to intubate
Time frame: 30 minutes
Esophageal intubation
Time frame: 30 minutes
Intubation failure
Time frame: 30 minutes
Arterial desaturation
Time frame: 30 minutes maximum
Perception of intubation difficulty by the operator
Time frame: 30 minutes
Impact of videolaryngoscopy on hemodynamic variables
Time frame: 30 minutes
Evaluation of usual complications after tracheal intubation
Time frame: 24 hours
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 28 Oct 2021.
- Derived from this study: PubMed 34980609Belze O, Coppere Z, Ouattara J, Thion LA, Paqueron X, Devys JM, Ma S, Kennel T, Fischler M, Le Guen M. Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial. BMJ Open. 2022 Jan 3;12(1):e049275. doi: 10.1136/bmjopen-2021-049275.
- Individual participant dataSharing planned: Yes. Data will be available in the Dryad repository.
Related trials for Anesthesia
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Not yet recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Recruiting
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Dexmedetomidine, Total Intravenous Anesthesia
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.
Olivier Belze, MD principal investigator
Hopital Foch
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngoscope with video and Laryngoscope without video in people with Anesthesia, run by Hopital Foch at 4 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 5 inclusion and 5 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available (time frame: 30 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 NCT02926144, which also lists 1 linked publication.
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 28 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.