Tracheal IntubationMGM-EvalNCT02292901
McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope
A study testing Macintosh laryngoscope and McGrath Mac videolaryngoscope in people with Tracheal Intubation, run by Hopital Foch at 2 sites in France.
Trial summary
Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- Macintosh laryngoscope and McGrath Mac videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2014to May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for a general anesthesia with orotracheal intubation
Who cannot join
- predictable risk of difficult mask ventilation or of difficult tracheal intubation
- necessity of a rapid sequence induction
- contra-indication to sufentanil, to propofol, or to atracurium
- ENT, thoracic surgery, or intracranial surgery
Trial locations and contacts
2 sites in 1 country.
France2 sites
Institut Hospitalier Franco-Britannique
Levallois-Perret, Hauts de Seine, 92300
Hopital Foch
Suresnes, Hauts de Seine, 92151
About this study
Official title: Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope
Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.
- Conditions
- Tracheal Intubation
- Being tested
- Macintosh laryngoscope, McGrath Mac videolaryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh laryngoscopeDevice
McGrath Mac videolaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Tracheal intubation will be performed using a Macintosh laryngoscope Receives: Device: Macintosh laryngoscope |
| McGrath Mac videolaryngoscope | Experimental | Tracheal intubation will be performed using a McGrath Mac videolaryngoscope Receives: Device: McGrath Mac videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of tracheal intubation
Ease of intubation is measured using the Intubation Difficulty Scale (Adnet et al. Anesthesiology 1997;87(6):1290-1297)
Measured: 1 hour
Secondary outcomes (11)
Time to obtain the first capnogram (sec)
Measured: one hour
Score of Cormak and Lehane modified by Yentis
Measured: one hour
POGO (percentage of glottic opening) score
Measured: one hour
Rate of use of alternative techniques for intubation
Measured: one hour
Rate of esophageal intubation
Measured: one hour
Incidence of arterial oxygen desaturation (SpO2 <92%)
Measured: one hour
Rate of failure of tracheal intubation
Measured: one hour
Rate of hemodynamic abnormality
Measured: one hour
Postoperative throat pain
Measured: one day
Postoperative hoarseness
Measured: one day
Questionnaire of Salditt-Isabel
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Chandon, MD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292901
- Sponsor's protocol ID
- 2013/42
- Other IDs
- 2013-A01307-38
- Acronym
- MGM-Eval
- Status last verified
- Oct 2016
- First submitted
- 12 Nov 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Intubation With the McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope
- ClinicalTrials.gov ID
- NCT02292901
- Acronym / sponsor ID
- MGM-Eval / 2013/42
- Conditions
- Tracheal Intubation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 18 Nov 2014 (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.
Videolaryngoscopes become widely used. The aim of this study is to compare McGrath Mac videolaryngoscope to conventional MacIntosh laryngoscope in patients without known risk of difficult of mask ventilation and of tracheal intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macintosh laryngoscope | Active comparator | Device: Macintosh laryngoscopeTracheal intubation will be performed using a Macintosh laryngoscope |
| McGrath Mac videolaryngoscope | Experimental | Device: McGrath Mac videolaryngoscopeTracheal intubation will be performed using a McGrath Mac videolaryngoscope |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient scheduled for a general anesthesia with orotracheal intubation
Key exclusion criteria (4 listed)
- predictable risk of difficult mask ventilation or of difficult tracheal intubation
- necessity of a rapid sequence induction
- contra-indication to sufentanil, to propofol, or to atracurium
- ENT, thoracic surgery, or intracranial 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 |
|---|---|---|
| Macintosh laryngoscope | Device | Macintosh laryngoscope |
| McGrath Mac videolaryngoscope | Device | McGrath Mac videolaryngoscope |
Primary outcome
Ease of tracheal intubation
Time frame: 1 hour
Ease of intubation is measured using the Intubation Difficulty Scale (Adnet et al. Anesthesiology 1997;87(6):1290-1297)
11 secondary outcomes
Time to obtain the first capnogram (sec)
Time frame: one hour
Score of Cormak and Lehane modified by Yentis
Time frame: one hour
POGO (percentage of glottic opening) score
Time frame: one hour
Rate of use of alternative techniques for intubation
Time frame: one hour
Rate of esophageal intubation
Time frame: one hour
Incidence of arterial oxygen desaturation (SpO2 <92%)
Time frame: one hour
Rate of failure of tracheal intubation
Time frame: one hour
Rate of hemodynamic abnormality
Time frame: one hour
Postoperative throat pain
Time frame: one day
Postoperative hoarseness
Time frame: one day
Questionnaire of Salditt-Isabel
Time frame: one hour
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Michel Chandon, MD principal investigator
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh laryngoscope and McGrath Mac videolaryngoscope in people with Tracheal Intubation, run by Hopital Foch 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 4 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: stopped early, as of the sponsor's last update on 31 Oct 2016. 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 was stopped early. Results are not available in the source record.
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?
Ease of tracheal intubation (time frame: 1 hour). 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 31 Oct 2016.