Does McGRATH® MAC Videolaryngoscope Decrease the Number of People Required to Perform Intubation During Anesthesia ?

Anesthesia Clinical Trial

— MGM3  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02926144
• Other study ID #: 2016/05
• Secondary ID: 2016-A00056-45
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Laryngoscope with video
Intubation with video-laryngoscope McGrath with use of the video feature
• Laryngoscope without video
Endotracheal intubation with video-laryngoscope McGrath without use of the video feature

Locations

Country	Name	City	State
France	Institut Hospitalier Franco Britannique	Levallois-Perret
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Centre Clinical	Soyaux
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes
Secondary	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	30 minutes
Secondary	Intubation difficulty Scale (IDS)		30 minutes
Secondary	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.	30 minutes
Secondary	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	30 minutes
Secondary	Esophageal intubation	No capnograms during mechanical ventilation once intubation is performed	30 minutes
Secondary	Intubation failure	Based on the video recording	30 minutes
Secondary	Arterial desaturation	Based on the video recording: visualisation of a pulse oximetry inferior to 92%	30 minutes maximum
Secondary	Perception of intubation difficulty by the operator	Evaluation on a scale between zero (no difficulty at all) to ten (extremely difficult)	30 minutes
Secondary	Impact of videolaryngoscopy on hemodynamic variables	Based on the video recording: Blood pressure and heart beat on monitoring before and after video laryngoscopy	30 minutes
Secondary	Evaluation of usual complications after tracheal intubation	Sore throat or voice change noticed on day 1	24 hours