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

14. juni 2021 oppdatert av: Assistance Publique - Hôpitaux de Paris

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

150

Fase

  • Fase 3

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Videolaryngoscopy group
Enhet: 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
Annen: Direct laryngoscopy group
Enhet: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of successful intubation at the first attempt
Tidsramme: up 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.
up to 10 minutes post inclusion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of attempts needed for successful intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Time to intubate
Tidsramme: up 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
up to 10 minutes post inclusion
Reason of failure of the first-pass success
Tidsramme: up 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
up to 10 minutes post inclusion
Proportion of decision of switch in case of failure
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Proportion of difficult intubations
Tidsramme: up 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
up to 10 minutes post inclusion
Glottic view
Tidsramme: up 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
up to 10 minutes post inclusion
Proportion of cases who need for tools to optimize
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Proportion of cases needed crossovers to other rescue techniques
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Number of complications per and post-intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Type of complications per and post-intubation
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion
Number of deaths
Tidsramme: up to 10 minutes post inclusion
up to 10 minutes post inclusion

Samarbeidspartnere og etterforskere

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Sponsor

Assistance Publique - Hôpitaux de Paris

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

15. juni 2021

Primær fullføring (Forventet)

15. desember 2021

Studiet fullført (Forventet)

15. desember 2021

Datoer for studieregistrering

Først innsendt

7. juni 2021

Først innsendt som oppfylte QC-kriteriene

14. juni 2021

Først lagt ut (Faktiske)

18. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • K170405J

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