NCT02413723

Brief Summary

The aim of this study is to demonstrate that the rate of successful orotracheal intubation at first laryngoscopy will be higher in patients intubated with McGrath Mac videolaryngoscope compared to patients intubated with classical Macintosh laryngoscope in patients requiring an orotracheal intubation in ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 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

March 28, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

March 28, 2015

Last Update Submit

November 14, 2025

Conditions

Intratracheal Intubation in Critical Care

Keywords

intubationcritical carelaryngoscopevideolaryngoscopeintratracheal

Outcome Measures

Primary Outcomes (1)

  • Proportion of successful orotracheal intubation at first laryngoscopy

    Number of successful intubation at first laryngoscopy in one arm/number of included patients in the same arm.

    intubation procedure, an expected average of 15 minutes

Secondary Outcomes (2)

  • Proportion of successful orotracheal intubation all laryngoscopies pooled

    intubation procedure, an expected average of 15 minutes

  • Time to successful orotracheal intubation

    intubation procedure, an expected average of 15 minutes

Other Outcomes (10)

  • Cormack and Lehane grade

    intubation procedure, an expected average of 15 minutes

  • Percentage of glottic opening (POGO) score

    intubation procedure, an expected average of 15 minutes

  • Difficult Intubation

    intubation procedure, an expected average of 15 minutes

  • +7 more other outcomes

Study Arms (2)

Videolaryngoscope McGrath Mac

ACTIVE COMPARATOR

McGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation

Device: Videolaryngoscope

Standard laryngoscope

PLACEBO COMPARATOR

Macintosh laryngoscope will be used for laryngoscopy for patient's intubation

Device: Standard laryngoscope

Interventions

VideolaryngoscopeDEVICE

McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.

Also known as: Mc Grath videolaryngoscope
Videolaryngoscope McGrath Mac
Standard laryngoscopeDEVICE

Macintosh laryngoscope will be use for first attempt of intratracheal intubation.

Also known as: Macintosh laryngoscope
Standard laryngoscope

Eligibility Criteria

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

You may qualify if:

  • Requiring orotracheal intubation

You may not qualify if:

  • Contraindication to orotracheal intubation
  • Minor (\<18 )
  • Pregnant, parturient , or breast-feeding woman
  • Patient hospitalized without consent and/or deprived of liberty by court's decision
  • Patient under guardianship or curators
  • Lack of social insurance
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Louis Mourier

Colombes, 92701, France

Location

CHD Vendee

La Roche-sur-Yon, France

Location

CHU Orleans

Orléans, France

Location

CHU Saint Louis

Paris, 75010, France

Location

CHU Paris Cochin

Paris, 75014, France

Location

CHU Strasbourg Nouvel Hôpital Civil

Strasbourg, France

Location

CHU Tours

Tours, France

Location

Related Publications (3)

  • Lascarrou JB, Le Thuaut A, Reignier J. Intubation With Video Laryngoscopy vs Direct Laryngoscopy-Reply. JAMA. 2017 May 23;317(20):2131-2132. doi: 10.1001/jama.2017.4486. No abstract available.

    PMID: 28535229BACKGROUND

  • Bailly A, Lascarrou JB, Le Thuaut A, Boisrame-Helms J, Kamel T, Mercier E, Ricard JD, Lemiale V, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis Group. McGRATH MAC videolaryngoscope versus Macintosh laryngoscope for orotracheal intubation in intensive care patients: the randomised multicentre MACMAN trial study protocol. BMJ Open. 2015 Dec 23;5(12):e009855. doi: 10.1136/bmjopen-2015-009855.

    PMID: 26700287BACKGROUND

  • Lascarrou JB, Boisrame-Helms J, Bailly A, Le Thuaut A, Kamel T, Mercier E, Ricard JD, Lemiale V, Colin G, Mira JP, Meziani F, Messika J, Dequin PF, Boulain T, Azoulay E, Champigneulle B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Video Laryngoscopy vs Direct Laryngoscopy on Successful First-Pass Orotracheal Intubation Among ICU Patients: A Randomized Clinical Trial. JAMA. 2017 Feb 7;317(5):483-493. doi: 10.1001/jama.2016.20603.

    PMID: 28118659RESULT

Study Officials

  • Jean Baptiste Lascarrou, MD

    CHD Vendee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2015

First Posted

April 10, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations

FR(7)