McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in Critical Care Unit (MACMAN)

July 14, 2016 updated by: Centre Hospitalier Departemental Vendee
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Colombes, France, 92701
        • CHU Louis Mourier
      • La Roche Sur Yon, France
        • CHD Vendée
      • Orleans, France
        • CHU Orleans
      • Paris, France, 75014
        • CHU Paris Cochin
      • Paris, France, 75010
        • CHU Saint Louis
      • Strasbourg, France
        • CHU Strasbourg Nouvel Hôpital Civil
      • Tours, France
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Requiring orotracheal intubation

Exclusion Criteria:

  • Contraindication to orotracheal intubation
  • Time too short to allow inclusion and randomisation of patient (particularly cardiac arrest)
  • 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
  • Concomitant inclusion in a trial whose primary endpoint focuses on intubation procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Videolaryngoscope McGrath Mac
McGrath Mac videolaryngoscope will be used for laryngoscopy for patient's intubation
Device: Videolaryngoscope
McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.
Other Names:
  • Mc Grath videolaryngoscope
PLACEBO_COMPARATOR: Standard laryngoscope
Macintosh laryngoscope will be used for laryngoscopy for patient's intubation
Device: Standard laryngoscope
Macintosh laryngoscope will be use for first attempt of intratracheal intubation.
Other Names:
  • Macintosh laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of successful orotracheal intubation at first laryngoscopy
Time Frame: intubation procedure, an expected average of 15 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of successful orotracheal intubation all laryngoscopies pooled
Time Frame: intubation procedure, an expected average of 15 minutes
intubation procedure, an expected average of 15 minutes
Time to successful orotracheal intubation
Time Frame: intubation procedure, an expected average of 15 minutes
Defined by the time between the beginning of induction (injection of anesthetic drugs) and the time of confirmation of the intratracheal nature of the endotracheal tube (defined as apparition of first inflexion on the expired carbon dioxide curve)
intubation procedure, an expected average of 15 minutes

Other Outcome Measures

Outcome Measure
Time Frame
Cormack and Lehane grade
Time Frame: intubation procedure, an expected average of 15 minutes
intubation procedure, an expected average of 15 minutes
Percentage of glottic opening (POGO) score
Time Frame: intubation procedure, an expected average of 15 minutes
intubation procedure, an expected average of 15 minutes
Difficult Intubation
Time Frame: intubation procedure, an expected average of 15 minutes
intubation procedure, an expected average of 15 minutes
Resort to alternative intubation technique
Time Frame: intubation procedure, an expected average of 15 minutes
intubation procedure, an expected average of 15 minutes
Frequency of occurence of unexpected events
Time Frame: Discharge from Intensive Care unit, an expected average of 7 days
Discharge from Intensive Care unit, an expected average of 7 days
Mechanical ventilation duration
Time Frame: Time from extubation, an expected average of 6 days
Time from extubation, an expected average of 6 days
Intensive Care Unit length of stay
Time Frame: Discharge from Intensive Care unit, an expected average of 7 days
Discharge from Intensive Care unit, an expected average of 7 days
Hospital length of stay
Time Frame: Discharge from hospital, an expected average of 14 days
Discharge from hospital, an expected average of 14 days
Intensive Care Unit Mortality
Time Frame: Discharge from Intensive Care unit, an expected average of 7 days
Discharge from Intensive Care unit, an expected average of 7 days
Mortality at day 28
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Collaborators

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

March 28, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (ESTIMATE)

April 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-A00674-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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