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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: Laryngoscope with video; Device: Laryngoscope without video

• Registration Number: NCT02926144
• Lead Sponsor: Hopital Foch

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.

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 Timeline

• Study First Submitted: 2016-10-04
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Study Start: 2016-11-28
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngoscope with video	Laryngoscope with video	Use of the video-laryngoscope McGrath Mac with use of the video feature
Laryngoscope without video	Laryngoscope without video	Use of the video-laryngoscope McGrath Mac without use of the video feature

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Institut Hospitalier Franco Britannique; 🇫🇷 Levallois-Perret, France

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France

Centre Clinical; 🇫🇷 Soyaux, France

Hopital Foch; 🇫🇷 Suresnes, France