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Video Analysis of Prehospital Emergency Intubations

6 maja 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Rzeczywisty)

422

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Szwajcaria
- - Bern, Szwajcaria, 3011
    - Bern University Hospital and University of Bern

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dziecko
Dorosły
Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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).

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
First attempt intubation success rate Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Overall success rate Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University Hospital Inselspital, Berne

Śledczy

Główny śledczy: Lorenz Theiler, Prof., Department of Anaesthesiology and Pain Therapy, Bern University Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 lutego 2018

Zakończenie podstawowe (Rzeczywisty)

14 lutego 2019

Ukończenie studiów (Rzeczywisty)

14 lutego 2019

Daty rejestracji na studia

Pierwszy przesłany

17 kwietnia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 kwietnia 2019

Pierwszy wysłany (Rzeczywisty)

29 kwietnia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 maja 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 maja 2019

Ostatnia weryfikacja

1 maja 2019

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

2017-02104

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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