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Video Analysis of Prehospital Emergency Intubations

6. mai 2019 oppdatert av: University Hospital Inselspital, Berne

Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes

The Investigators' knowledge about pre-hospital emergency intubations is still limited. Various factors such as the average and the normal range of intubation time are still unknown. Since its launch Rega videotapes all intubation attempts with the C-MAC videolaryngoscope. The investigators prospectively analysed all routinely recorded intubation videos during one year performed by the Rega crews. The investigators analysed different parameters such as first pass success rate and the time to successfully intubate alongside with others. The goal was to find out more about this difficult procedure, about the problems which regularly occur and on what should be put particular emphasis during training.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Pre-hospital emergency intubations are especially hazardous. The incidence of unanticipated difficult airways is higher (9,3 % of prehospital intubations are more difficult than anticipated). The first attempt intubation success rates are lower and the rate of complications compared to in-hospital emergency intubations is higher.

There is conflicting evidence if first attempt intubation success rate in prehospital intubations differs between intubations performed by videolaryngoscopy and direct laryngoscopy. On the other hand in pre-hospital airway management, the use of a C-MAC videolaryngoscope improved the visualization of glottic structures significantly.

The C-MAC has recently launched a new version, which allows videotaping of intubations. Rega decided to videotape all intubation attempts for legal purposes and quality control. These videos are stored at a Rega-based secure central database.

The Investigators knowledge there is only one video-enhanced retrospective analyses of a limited number of videolaryngoscopic pre-hospital intubations.

So far, there is no video-enhanced prospective analysis of first attempt intubation success rates or of the time necessary for successful intubation with videolaryngoscopes in the pre-hospital setting available. Therefore, the investigators intend to determine the exact first attempt intubation success rate and the time necessary to successfully intubate, alongside with parameters such as the Cormack/Lehane grade, blade position (Macintosh vs Miller) and others (e.g. difficulties during intubation) in the pre-hospital physician-staffed HEMS-setting. The investigators' goal is to learn more about what is actually happening during prehospital intubations and what type of difficulties may occur.

The investigators therefore prospectively analysed all routinely recorded intubation videos (using the built-in camera of the C-MAC videolaryngoscope) during one year performed by the Rega crews. These videos show real life intubations through the video function included in the device, only the image from the tip of the laryngoscopy blade inside the patient's mouth is recorded. The operating physicians additionally provided anonymous information about intubation management for each video after returning to the helicopter base

Studietype

Observasjonsmessig

Registrering (Faktiske)

422

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Bern, Sveits, 3011
        • Bern University Hospital and University of Bern

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All Patients which underwent Intubation performed by the Rega during 1year (15.02.18-14.02.19) because of medical or Trauma associated reasons (with or without cardiac arrest).

Beskrivelse

Inclusion Criteria:

• All videos routinely taken from intubations performed during 1 year at the Swiss Air Rescue (Rega) at all 13 helicopter bases

Exclusion Criteria:

  • Patients who were intubated primarily using other devices without a camera
  • Intubations that were not recorded (missing data).

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First attempt intubation success rate
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Rate of a successful intubation at first attempt
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall success rate
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The overall rate of successful intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Time intervals during intubation
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
entry-to-tube time (C-MAC crossing the lips to first appearance of tracheal tube in the field of view), time to intubation (C-MAC crossing the lips for the first time until passage of the tube through the vocal cords, the video is kept running throughout the intubation procedure), time between passage of the tube until removal of the blade from the mouth, overall time (from C-MAC crossing the lips for the first time until removal, the video is kept running throughout the intubation procedure), tube time (time from first appearance of the tube in the field until passage of the tube through the vocal cords), intubation time of the successful intubation attempt (C-MAC crossing the lips in the successful attempt until passage of the tube through vocal cords)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of intubation attempts
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The total number of attempts needed for the intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
The best C/L and best POGO score achieved during the intubation
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Additional Airway devices used
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
If additional devices have been used (e.g. Frova-like,catheter, Magill forceps, suction catheter)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of glottic hits
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Number of attempts to advance the tracheal tube, but only glottic structures are being hit
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Blade positioning
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Blade positioning during intubation (Macintosh vs. Miller)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Unintended blade positions
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Unintended blade positions (too deep, downfolding of epiglottis)
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Secretion in the mouth and difficulties in visualisation because of it
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Vomit, blood, saliva
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Fogging of the camera
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
videolaryngoscope camera clear or fog
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Oesophageal intubation
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Oesophageal fail intubation during the procedure
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Injury of the pharyngeal mucose due to the blade
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Videolaryngoscope injury of the pharyngeal mucose due to the blade
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Open or Closed vocal cords
Tidsramme: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Positioning of vocal cords if visible (open, closed), start of movement of vocal cords
Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital Inselspital, Berne

Etterforskere

  • Hovedetterforsker: Lorenz Theiler, Prof., Department of Anaesthesiology and Pain Therapy, Bern University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 (Faktiske)

15. februar 2018

Primær fullføring (Faktiske)

14. februar 2019

Studiet fullført (Faktiske)

14. februar 2019

Datoer for studieregistrering

Først innsendt

17. april 2019

Først innsendt som oppfylte QC-kriteriene

24. april 2019

Først lagt ut (Faktiske)

29. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2017-02104

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