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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03929796
Other study ID # 2017-02104
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2018
Est. completion date February 14, 2019

Study information

Verified date May 2019
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 422
Est. completion date February 14, 2019
Est. primary completion date February 14, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Bern University Hospital and University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary First attempt intubation success rate 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
Secondary Overall success rate 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
Secondary Time intervals during intubation 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
Secondary Number of intubation attempts 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
Secondary Best C/L(Cormack/ Lehane 1-4) grade and best POGO (percent of glottis Opening 0 - 100 %) score 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
Secondary Additional Airway devices used 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
Secondary Number of glottic hits 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
Secondary Blade positioning 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
Secondary Unintended blade positions 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
Secondary Secretion in the mouth and difficulties in visualisation because of it Vomit, blood, saliva Starts when the videolaryngoscope is inserted in the patients mouth for the first time and ends when the airway is secured
Secondary Fogging of the camera 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
Secondary Oesophageal intubation 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
Secondary Injury of the pharyngeal mucose due to the blade 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
Secondary Open or Closed vocal cords 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
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