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

November 14, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
371

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Vendee
      • Orléans, France
        • CHU Orléans
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Departemental Vendee

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nantes University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Baptiste Lascarrou, MD, CHD Vendee

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Intratracheal Intubation in Critical Care

Clinical Trials on Videolaryngoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings