MGM3: Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Laryngoscope with video Use of the video-laryngoscope McGrath Mac with use of the video feature |
Device: Laryngoscope with video
Intubation with video-laryngoscope McGrath with use of the video feature
Other Names:
|
| Active Comparator: Laryngoscope without video Use of the video-laryngoscope McGrath Mac without use of the video feature |
Device: Laryngoscope without video
Endotracheal intubation with video-laryngoscope McGrath without use of the video feature
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of people needed for tracheal intubation when the video feature of McGRATH® MAC videolaryngoscope is available [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.
Secondary Outcome Measures
- Cooperation between members of the anesthesiology team during intubation [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
- Intubation difficulty Scale (IDS) [30 minutes]
- Number of hands necessary for tracheal intubation [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.
- Time to intubate [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
- Esophageal intubation [30 minutes]
No capnograms during mechanical ventilation once intubation is performed
- Intubation failure [30 minutes]
Based on the video recording
- Arterial desaturation [30 minutes maximum]
Based on the video recording: visualisation of a pulse oximetry inferior to 92%
- Perception of intubation difficulty by the operator [30 minutes]
Evaluation on a scale between zero (no difficulty at all) to ten (extremely difficult)
- Impact of videolaryngoscopy on hemodynamic variables [30 minutes]
Based on the video recording: Blood pressure and heart beat on monitoring before and after video laryngoscopy
- Evaluation of usual complications after tracheal intubation [24 hours]
Sore throat or voice change noticed on day 1
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 18 years old minimum
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Requiring general anesthesia and orotracheal intubation with a single lumen tube
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Having signed an inform consent form
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Having a telephone and agreeing to communicate their phone number
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Benefiting from a social insurance scheme or beneficiary
Exclusion Criteria:
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Pregnant or breast-feeding women
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Patients taken care in ambulatory surgery who could not be contacted within 24 hours following surgery
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Patients having a predicted difficult intubation (Arné's score ≥ 11) or predicted difficult mask ventilation
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patients requiring a rapid-sequence intubation
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patients for whom general anesthesia using sufentanil, propofol, atracurium or rocuronium is not suitable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Hospitalier Franco Britannique | Levallois-Perret | France | 92300 | |
| 2 | Fondation Ophtalmologique Adolphe de Rothschild | Paris | France | 75019 | |
| 3 | Centre Clinical | Soyaux | France | 16800 | |
| 4 | Hopital Foch | Suresnes | France | 92150 |
Sponsors and Collaborators
- Hopital Foch
Investigators
- Principal Investigator: Olivier Belze, MD, Hopital Foch
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2016/05
- 2016-A00056-45