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Video Analysis of Prehospital Emergency Intubations

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ClinicalTrials.gov Identifier: NCT03929796
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease
Intubation Prehospital Videolaryngoscopy

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


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Study Type : Observational
Actual Enrollment : 422 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Prehospital Emergency Intubations Using Videolaryngoscopes
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 14, 2019



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929796


Locations
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Switzerland
Bern University Hospital and University of Bern
Bern, Switzerland, 3011
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lorenz Theiler, Prof. Department of Anaesthesiology and Pain Therapy, Bern University Hospital

Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03929796     History of Changes
Other Study ID Numbers: 2017-02104
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes