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

NCT04930419 | Unknown Phase 3

• 1 other identifier: K170405J
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Indication of Orotracheal Intubation; Cardio Respiratory Arrest; Respiratory Failure; Neurological Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of attempts needed for successful intubation

  up to 10 minutes post inclusion

• Time to intubate

  up to 10 minutes post inclusion

• Reason of failure of the first-pass success

  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

  up to 10 minutes post inclusion

Study Arms (2)

Videolaryngoscopy group

OTHER

Device: Videolaryngoscopy group

Direct laryngoscopy group

OTHER

Device: Direct laryngoscopy group

Interventions

Videolaryngoscopy group DEVICE

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

Videolaryngoscopy group

Direct laryngoscopy group DEVICE

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

Direct laryngoscopy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Heart Arrest; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Baudoin Clémence

CONTACT

+331 49 95 61 61; clemence.baudoin@aphp.fr

Matthieu Resche-Rigon

CONTACT

+33142499773; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: June 15, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-05