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

NCT ID: NCT02926144

Last Updated: 2021-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-28

Study Completion Date

2019-04-01

Brief Summary

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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

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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.

Conditions

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Anesthesia

Keywords

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Intratracheal intubation videolaryngoscope McGrath MAC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laryngoscope with video

Use of the video-laryngoscope McGrath Mac with use of the video feature

Group Type EXPERIMENTAL

Laryngoscope with video

Intervention Type DEVICE

Intubation with video-laryngoscope McGrath with use of the video feature

Laryngoscope without video

Use of the video-laryngoscope McGrath Mac without use of the video feature

Group Type ACTIVE_COMPARATOR

Laryngoscope without video

Intervention Type DEVICE

Endotracheal intubation with video-laryngoscope McGrath without use of the video feature

Interventions

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Laryngoscope with video

Intubation with video-laryngoscope McGrath with use of the video feature

Intervention Type DEVICE

Laryngoscope without video

Endotracheal intubation with video-laryngoscope McGrath without use of the video feature

Intervention Type DEVICE

Other Intervention Names

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Endotracheal intubation with laryngoscope video feature Intubation without the laryngoscope video feature

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Belze, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Institut Hospitalier Franco Britannique

Levallois-Perret, , France

Site Status

Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Centre Clinical

Soyaux, , France

Site Status

Hopital Foch

Suresnes, , France

Site Status

Countries

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France

References

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Belze O, Coppere Z, Ouattara J, Thion LA, Paqueron X, Devys JM, Ma S, Kennel T, Fischler M, Le Guen M. Influence of videolaryngoscopy using McGrath Mac on the need for a helper to perform intubation during general anaesthesia: a multicentre randomised video-no-video trial. BMJ Open. 2022 Jan 3;12(1):e049275. doi: 10.1136/bmjopen-2021-049275.

Reference Type DERIVED
PMID: 34980609 (View on PubMed)

Other Identifiers

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2016-A00056-45

Identifier Type: OTHER

Identifier Source: secondary_id

2016/05

Identifier Type: -

Identifier Source: org_study_id