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Completed

NCT Number: NCT03929796

Video Analysis of Prehospital Emergency Intubations

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.

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Key information

Conditions

Intubation Prehospital Videolaryngoscopy

Sex eligibility

All sexes

Study type

Observational

Primary location

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. First attempt intubation success rate

    Time frame: 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

Secondary outcomes

  1. Overall success rate

    Time frame: 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

  2. Time intervals during intubation

    Time frame: 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)

  3. Number of intubation attempts

    Time frame: 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

  4. Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score

    Time frame: 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

  5. Additional Airway devices used

    Time frame: 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)

  6. Number of glottic hits

    Time frame: 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

  7. Blade positioning

    Time frame: 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)

  8. Unintended blade positions

    Time frame: 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)

  9. Secretion in the mouth and difficulties in visualisation because of it

    Time frame: Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured

    Vomit, blood, saliva

  10. Fogging of the camera

    Time frame: 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

  11. Oesophageal intubation

    Time frame: 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

  12. Injury of the pharyngeal mucose due to the blade

    Time frame: 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

  13. Open or Closed vocal cords

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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