NCT03929796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

April 17, 2019

Last Update Submit

May 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Overall success rate

    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

    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

    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

    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

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

  • +8 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • All videos routinely taken from intubations performed during 1 year at the Swiss Air Rescue (Rega) at all 13 helicopter bases

You may not qualify if:

  • Patients who were intubated primarily using other devices without a camera
  • Intubations that were not recorded (missing data).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital and University of Bern

Bern, 3011, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 25886716BACKGROUND
  • 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.

    PMID: 22191806BACKGROUND
  • 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.

    PMID: 30172693BACKGROUND
  • 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.

    PMID: 19104110BACKGROUND
  • 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.

    PMID: 30336234BACKGROUND

Study Officials

  • Lorenz Theiler, Prof.

    Department of Anaesthesiology and Pain Therapy, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 29, 2019

Study Start

February 15, 2018

Primary Completion

February 14, 2019

Study Completion

February 14, 2019

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations