- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03929796
Video Analysis of Prehospital Emergency Intubations
Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes
Přehled studie
Postavení
Podmínky
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
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Bern, Švýcarsko, 3011
- Bern University Hospital and University of Bern
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
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)
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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
Vyšetřovatelé
- Vrchní vyšetřovatel: Lorenz Theiler, Prof., Department of Anaesthesiology and Pain Therapy, Bern University Hospital
Publikace a užitečné odkazy
Obecné publikace
- Carlson JN, Quintero J, Guyette FX, Callaway CW, Menegazzi JJ. Variables associated with successful intubation attempts using video laryngoscopy: a preliminary report in a helicopter emergency medical service. Prehosp Emerg Care. 2012 Apr-Jun;16(2):293-8. doi: 10.3109/10903127.2011.640764. Epub 2011 Dec 22.
- Hossfeld B, Frey K, Doerges V, Lampl L, Helm M. Improvement in glottic visualisation by using the C-MAC PM video laryngoscope as a first-line device for out-of-hospital emergency tracheal intubation: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):425-31. doi: 10.1097/EJA.0000000000000249.
- Kim SY, Park SO, Kim JW, Sung J, Lee KR, Lee YH, Hong DY, Baek KJ. How much experience do rescuers require to achieve successful tracheal intubation during cardiopulmonary resuscitation? Resuscitation. 2018 Dec;133:187-192. doi: 10.1016/j.resuscitation.2018.08.032. Epub 2018 Aug 30.
- Gunning M, O'Loughlin E, Fletcher M, Crilly J, Hooper M, Ellis DY. Emergency intubation: a prospective multicentre descriptive audit in an Australian helicopter emergency medical service. Emerg Med J. 2009 Jan;26(1):65-9. doi: 10.1136/emj.2008.059345.
- Smith CM, Yeung J. Airway management in cardiac arrest-Not a question of choice but of quality? Resuscitation. 2018 Dec;133:A5-A6. doi: 10.1016/j.resuscitation.2018.10.009. Epub 2018 Oct 15. No abstract available.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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