NCT02926144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

October 4, 2016

Last Update Submit

October 20, 2021

Conditions

Anesthesia

Keywords

Intratracheal intubationvideolaryngoscopeMcGrath MAC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Cooperation between members of the anesthesiology team during intubation

    30 minutes

  • Intubation difficulty Scale (IDS)

    30 minutes

  • Number of hands necessary for tracheal intubation

    30 minutes

  • Time to intubate

    30 minutes

  • Esophageal intubation

    30 minutes

  • +5 more secondary outcomes

Study Arms (2)

Laryngoscope with video

EXPERIMENTAL

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

Device: Laryngoscope with video

Laryngoscope without video

ACTIVE COMPARATOR

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

Device: Laryngoscope without video

Interventions

Laryngoscope with videoDEVICE

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

Also known as: Endotracheal intubation with laryngoscope video feature
Laryngoscope with video
Laryngoscope without videoDEVICE

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

Also known as: Intubation without the laryngoscope video feature
Laryngoscope without video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut Hospitalier Franco Britannique

Levallois-Perret, 92300, France

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Centre Clinical

Soyaux, 16800, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • 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.

    PMID: 34980609DERIVED

MeSH Terms

Interventions

LaryngoscopesIntubation, IntratrachealIntubation

Intervention Hierarchy (Ancestors)

EndoscopesDiagnostic EquipmentEquipment and SuppliesSurgical EquipmentAirway ManagementTherapeuticsInvestigative Techniques

Study Officials

  • Olivier Belze, MD

    Hopital Foch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 6, 2016

Study Start

November 28, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

October 28, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Data will be available in the Dryad repository.

Shared Documents
ANALYTIC CODE
Time Frame
After publication in a peer-review journal. No limit in time
Access Criteria
No criteria
More information

Locations

FR(4)