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Video Analysis of Prehospital Emergency Intubations

6. května 2019 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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

Typ studie

Pozorovací

Zápis (Aktuální)

422

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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).

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
First attempt intubation success rate
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall success rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

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

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. února 2018

Primární dokončení (Aktuální)

14. února 2019

Dokončení studie (Aktuální)

14. února 2019

Termíny zápisu do studia

První předloženo

17. dubna 2019

První předloženo, které splnilo kritéria kontroly kvality

24. dubna 2019

První zveřejněno (Aktuální)

29. dubna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

6. května 2019

Naposledy ověřeno

1. května 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2017-02104

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Studuje lékový produkt regulovaný americkým FDA

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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