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Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting (AMAC)

Primary Purpose

Indication of Orotracheal Intubation, Cardio Respiratory Arrest, Respiratory Failure

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Videolaryngoscopy group
Direct laryngoscopy group
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Indication of Orotracheal Intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age more than 18
  • Indication of orotracheal intubation
  • Operators trained to the use of the McGrath

Exclusion Criteria:

  • Pregnancy
  • No insurance
  • Major patient under guardianship or curatorship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Videolaryngoscopy group

    Direct laryngoscopy group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rate of successful intubation at the first attempt
    One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.

    Secondary Outcome Measures

    Number of attempts needed for successful intubation
    Time to intubate
    Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
    Reason of failure of the first-pass success
    Reasons of failure will be defined as following : Bad glottic visualization Difficult progression of the tube towards the glottis despite a good visualisation Presence of secretions Presence of foreign body Presence of fogging on the McGrath Device failure Other
    Proportion of decision of switch in case of failure
    Proportion of difficult intubations
    Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ). It goes from 0 to infinity. zero indicating an easy intubation and infinity being an impossible intubation
    Glottic view
    Glottic view will be evaluated with Cormack and Lehane grade and POGO score. POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis). Cormack and Lehane grade goes from I to IV. A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
    Proportion of cases who need for tools to optimize
    Proportion of cases needed crossovers to other rescue techniques
    Number of complications per and post-intubation
    Type of complications per and post-intubation
    Number of deaths

    Full Information

    First Posted
    June 7, 2021
    Last Updated
    June 14, 2021
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04930419
    Brief Title
    Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
    Acronym
    AMAC
    Official Title
    Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 15, 2021 (Anticipated)
    Primary Completion Date
    December 15, 2021 (Anticipated)
    Study Completion Date
    December 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the prehospital setting, the risk of difficult intubation and life-threatening complications is increased under particular conditions due to the environment or the frequent instability of patients. To limit this risk procedures and devices to ease and secure tracheal intubation must be developped and integrated. As the prevalence of complications increase with the number of attempts of intubation, one strategy is to facilitate the intubation technic itself. Direct laryngoscopy with Macintosh blades is the standard device commonly used in first place for tracheal intubation. Other devices are available and used, mostly for difficult intubation, included videolaryngoscopy. This device has been used and studied for years now. Allowing a better view and glottic visualisation, videolaryngoscopy could increase the first-pass success rate. Among all videolaryngoscopes, the McGrath videolaryngoscope is the most similar device to the standard Macintosh laryngoscope. It is light, compact, with a screen directly linked to the handle, easy to use and offering excellent view. Its usability and efficacy make it a device of choice for the prehospital setting and worth further clinical trials to define its place in the airway strategy. Hypothesis: In the prehospital setting, the use of McGrath videolaryngoscope as the primary device for tracheal intubation could facilitate tracheal intubation and decrease the number of attempts of intubation and complications. The objective of our study is to determine if the use of McGrath videolaryngoscope increase the rate of successful first-pass intubation in the prehospital setting compared to direct view Macintosh laryngoscopy. The primary outcome is the rate of successful intubation at the first attempt. One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt. Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Indication of Orotracheal Intubation, Cardio Respiratory Arrest, Respiratory Failure, Neurological Failure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Videolaryngoscopy group
    Arm Type
    Other
    Arm Title
    Direct laryngoscopy group
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Videolaryngoscopy group
    Intervention Description
    Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
    Intervention Type
    Device
    Intervention Name(s)
    Direct laryngoscopy group
    Intervention Description
    Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention. and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
    Primary Outcome Measure Information:
    Title
    Rate of successful intubation at the first attempt
    Description
    One attempt is defined as an advancement of the tube towards the glottis during a laryngoscopy ; every new try even during the same laryngoscopy is considered as a new attempt.Successful intubation is confirmed by the visualisation of 6 waves of EtCO2.
    Time Frame
    up to 10 minutes post inclusion
    Secondary Outcome Measure Information:
    Title
    Number of attempts needed for successful intubation
    Time Frame
    up to 10 minutes post inclusion
    Title
    Time to intubate
    Description
    Time to intubate will be defined by the time between the insertion of the device in the mouth and the visualisation of the first waves of EtCO2
    Time Frame
    up to 10 minutes post inclusion
    Title
    Reason of failure of the first-pass success
    Description
    Reasons of failure will be defined as following : Bad glottic visualization Difficult progression of the tube towards the glottis despite a good visualisation Presence of secretions Presence of foreign body Presence of fogging on the McGrath Device failure Other
    Time Frame
    up to 10 minutes post inclusion
    Title
    Proportion of decision of switch in case of failure
    Time Frame
    up to 10 minutes post inclusion
    Title
    Proportion of difficult intubations
    Description
    Difficult intubation will be evaluated by the intubation difficulty score (score IDS or difficulty of intubation under laryngoscopy score ). It goes from 0 to infinity. zero indicating an easy intubation and infinity being an impossible intubation
    Time Frame
    up to 10 minutes post inclusion
    Title
    Glottic view
    Description
    Glottic view will be evaluated with Cormack and Lehane grade and POGO score. POGO score goes from 0 (Visualization of the language base) to 100% (total visualization of the glottis). Cormack and Lehane grade goes from I to IV. A higher Cormack and Lehane grade is worth : I indicate total visualization of the glottis and IV indicate Visualization of the language base
    Time Frame
    up to 10 minutes post inclusion
    Title
    Proportion of cases who need for tools to optimize
    Time Frame
    up to 10 minutes post inclusion
    Title
    Proportion of cases needed crossovers to other rescue techniques
    Time Frame
    up to 10 minutes post inclusion
    Title
    Number of complications per and post-intubation
    Time Frame
    up to 10 minutes post inclusion
    Title
    Type of complications per and post-intubation
    Time Frame
    up to 10 minutes post inclusion
    Title
    Number of deaths
    Time Frame
    up to 10 minutes post inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age more than 18 Indication of orotracheal intubation Operators trained to the use of the McGrath Exclusion Criteria: Pregnancy No insurance Major patient under guardianship or curatorship
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Baudoin Clémence
    Phone
    +331 49 95 61 61
    Email
    clemence.baudoin@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthieu Resche-Rigon
    Phone
    +33142499773
    Email
    matthieu.resche-rigon@u-paris.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting

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