Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ? (MGM3)
October 20, 2021 updated by: Hopital Foch
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Levallois-Perret, France, 92300
- Institut Hospitalier Franco Britannique
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Paris, France, 75019
- Fondation Ophtalmologique Adolphe de Rothschild
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Soyaux, France, 16800
- Centre Clinical
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Suresnes, France, 92150
- Hopital Foch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laryngoscope with video
Use of the video-laryngoscope McGrath Mac with use of the video feature
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Intubation with video-laryngoscope McGrath with use of the video feature
Other Names:
|
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Active Comparator: Laryngoscope without video
Use of the video-laryngoscope McGrath Mac without use of the video feature
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Endotracheal intubation with video-laryngoscope McGrath without use of the video feature
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cooperation between members of the anesthesiology team during intubation
Time Frame: 30 minutes
|
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
|
30 minutes
|
|
Intubation difficulty Scale (IDS)
Time Frame: 30 minutes
|
30 minutes
|
|
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Number of hands necessary for tracheal intubation
Time Frame: 30 minutes
|
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.
|
30 minutes
|
|
Time to intubate
Time Frame: 30 minutes
|
Based on the video recording: from the entrance of the blade in the patient's mouth until the presence of the first capnogram
|
30 minutes
|
|
Esophageal intubation
Time Frame: 30 minutes
|
No capnograms during mechanical ventilation once intubation is performed
|
30 minutes
|
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Intubation failure
Time Frame: 30 minutes
|
Based on the video recording
|
30 minutes
|
|
Arterial desaturation
Time Frame: 30 minutes maximum
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Based on the video recording: visualisation of a pulse oximetry inferior to 92%
|
30 minutes maximum
|
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Perception of intubation difficulty by the operator
Time Frame: 30 minutes
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Evaluation on a scale between zero (no difficulty at all) to ten (extremely difficult)
|
30 minutes
|
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Impact of videolaryngoscopy on hemodynamic variables
Time Frame: 30 minutes
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Based on the video recording: Blood pressure and heart beat on monitoring before and after video laryngoscopy
|
30 minutes
|
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Evaluation of usual complications after tracheal intubation
Time Frame: 24 hours
|
Sore throat or voice change noticed on day 1
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olivier Belze, MD, Hopital Foch
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
October 4, 2016
First Submitted That Met QC Criteria
October 5, 2016
First Posted (Estimate)
October 6, 2016
Study Record Updates
Last Update Posted (Actual)
October 28, 2021
Last Update Submitted That Met QC Criteria
October 20, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2016/05
- 2016-A00056-45 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be available in the Dryad repository.
IPD Sharing Time Frame
After publication in a peer-review journal.
No limit in time
IPD Sharing Access Criteria
No criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.