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

Phase 3
Conditions
Respiratory Failure
Cardio Respiratory Arrest
Indication of Orotracheal Intubation
Neurological Failure
Interventions
Device: Direct laryngoscopy group
Device: Videolaryngoscopy group
Registration Number
NCT04930419
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Direct laryngoscopy groupDirect laryngoscopy group-
Videolaryngoscopy groupVideolaryngoscopy group-
Primary Outcome Measures
NameTimeMethod
Rate of successful intubation at the first attemptup to 10 minutes post inclusion

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
NameTimeMethod
Number of attempts needed for successful intubationup to 10 minutes post inclusion
Proportion of difficult intubationsup to 10 minutes post inclusion

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

Type of complications per and post-intubationup to 10 minutes post inclusion
Time to intubateup to 10 minutes post inclusion

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 successup to 10 minutes post inclusion

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

Glottic viewup to 10 minutes post inclusion

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 needed crossovers to other rescue techniquesup to 10 minutes post inclusion
Proportion of cases who need for tools to optimizeup to 10 minutes post inclusion
Proportion of decision of switch in case of failureup to 10 minutes post inclusion
Number of deathsup to 10 minutes post inclusion
Number of complications per and post-intubationup to 10 minutes post inclusion
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