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

NCT ID: NCT04930419

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2021-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Videolaryngoscopy group

Group Type: OTHER

Videolaryngoscopy group

Intervention Type: 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

Direct laryngoscopy group

Group Type: OTHER

Direct laryngoscopy group

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Baudoin Clémence

Role: CONTACT

clemence.baudoin@aphp.fr

+331 49 95 61 61

Matthieu Resche-Rigon

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

+33142499773

Other Identifiers

K170405J

Identifier Type: -

Identifier Source: org_study_id