Clinical trial NCT03929796: Video Analysis of Prehospital Emergency Intubations
Official title: Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation
Prehospital
Videolaryngoscopy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 422
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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).

Primary outcomes:
measure: First attempt intubation success rate
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Secondary outcomes:
measure: Overall success rate
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Time intervals during intubation
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Number of intubation attempts
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Additional Airway devices used
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Number of glottic hits
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Blade positioning
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Unintended blade positions
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Secretion in the mouth and difficulties in visualisation because of it
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Fogging of the camera
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Oesophageal intubation
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Injury of the pharyngeal mucose due to the blade
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
measure: Open or Closed vocal cords
timeFrame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital and University of Bern
Study officials:
affiliation: Department of Anaesthesiology and Pain Therapy, Bern University Hospital
name: Lorenz Theiler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.