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
About this trial
This is an interventional other trial for Indication of Orotracheal Intubation
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
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
NCT ID
NCT04930419
First Posted
June 7, 2021
Last Updated
June 14, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
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
Learn more about this trial
Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
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