Clinical trial NCT04930419: Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
Official title: Comparative Evaluation of the McGrath Videolaryngoscope and the Direct Laryngoscopy for Tracheal Intubation in the Prehospital Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Indication of Orotracheal Intubation
Cardio Respiratory Arrest
Respiratory Failure
Neurological Failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Rate of successful intubation at the first attempt
timeFrame: up to 10 minutes post inclusion
Secondary outcomes:
measure: Number of attempts needed for successful intubation
timeFrame: up to 10 minutes post inclusion
measure: Time to intubate
timeFrame: up to 10 minutes post inclusion
measure: Reason of failure of the first-pass success
timeFrame: up to 10 minutes post inclusion
measure: Proportion of decision of switch in case of failure
timeFrame: up to 10 minutes post inclusion
measure: Proportion of difficult intubations
timeFrame: up to 10 minutes post inclusion
measure: Glottic view
timeFrame: up to 10 minutes post inclusion
measure: Proportion of cases who need for tools to optimize
timeFrame: up to 10 minutes post inclusion
measure: Proportion of cases needed crossovers to other rescue techniques
timeFrame: up to 10 minutes post inclusion
measure: Number of complications per and post-intubation
timeFrame: up to 10 minutes post inclusion
measure: Type of complications per and post-intubation
timeFrame: up to 10 minutes post inclusion
measure: Number of deaths
timeFrame: up to 10 minutes post inclusion
Other outcomes:
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