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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Cardio Respiratory Arrest; Indication of Orotracheal Intubation; Neurological Failure
• Intervention / Treatment: Device: Videolaryngoscopy group; Device: Direct laryngoscopy group

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Baudoin Clémence; Phone Number: +331 49 95 61 61; Email: clemence.baudoin@aphp.fr
• Study Contact Backup: Name: Matthieu Resche-Rigon; Phone Number: +33142499773; Email: matthieu.resche-rigon@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Videolaryngoscopy group	Device: Videolaryngoscopy group; 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
Other: Direct laryngoscopy group	Device: Direct laryngoscopy group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 10 minutes post inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts needed for successful intubation		up to 10 minutes post inclusion
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	up to 10 minutes post inclusion
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	up to 10 minutes post inclusion
Proportion of decision of switch in case of failure		up to 10 minutes post inclusion
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	up to 10 minutes post inclusion
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	up to 10 minutes post inclusion
Proportion of cases who need for tools to optimize		up to 10 minutes post inclusion
Proportion of cases needed crossovers to other rescue techniques		up to 10 minutes post inclusion
Number of complications per and post-intubation		up to 10 minutes post inclusion
Type of complications per and post-intubation		up to 10 minutes post inclusion
Number of deaths		up to 10 minutes post inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2021
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): December 15, 2021

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: K170405J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No