Clinical trial NCT02733536: Intubation During Spinal Immobilization
Official title: C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Keywords: endotracheal intubation
trauma
paramedic
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim was to evaluate the performance of the C-MAC compared with Macintosh when performed in patients with immobilized cervical spine by unexperienced physicians.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* limited experience (\<5 intubations) with "real-life" intubation using direct laryngoscopy
* novice phhysicians

Exclusion Criteria:

* not meet the above criteria
* practice with any videolaryngoscopy
* wrist or low back diseases
* pregnancy

Primary outcomes:
measure: Time required for successful intubation
timeFrame: 1 day
Secondary outcomes:
measure: success rate of intubation attempt
timeFrame: 1 day
measure: Cormack&Lehane grade
timeFrame: 1 day
measure: Dental Compression
timeFrame: 1 day
measure: Ease of intubation
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
affiliation: Medical University of Warsaw
name: Łukasz Szarpak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Truszewski Z, Szarpak L, Smereka J, Kurowski A, Evrin T, Czyzewski L. Comparison of the VivaSight single lumen endotracheal tube and the Macintosh laryngoscope for emergency intubation by experienced paramedics in a standardized airway manikin with restricted access: a randomized, crossover trial. Am J Emerg Med. 2016 May;34(5):929-30. doi: 10.1016/j.ajem.2016.02.054. Epub 2016 Feb 27. No abstract available.
citation: Bogdanski L, Truszewski Z, Kurowski A, Czyzewski L, Zasko P, Adamczyk P, Szarpak L. Simulated endotracheal intubation of a patient with cervical spine immobilization during resuscitation: a randomized comparison of the Pentax AWS, the Airtraq, and the McCoy Laryngoscopes. Am J Emerg Med. 2015 Dec;33(12):1814-7. doi: 10.1016/j.ajem.2015.09.005. Epub 2015 Sep 21.
citation: Gawlowski P, Smereka J, Madziala M, Szarpak L, Frass M, Robak O. Comparison of the Macintosh laryngoscope and blind intubation via the iGEL for Intubation With C-spine immobilization: A Randomized, crossover, manikin trial. Am J Emerg Med. 2017 Mar;35(3):484-487. doi: 10.1016/j.ajem.2016.11.064. Epub 2016 Nov 30.
citation: Karczewska K, Szarpak L, Smereka J, Dabrowski M, Ladny JR, Wieczorek W, Robak O, Frass M, Ahuja S, Ruetzler K. ET-View compared to direct laryngoscopy in patients with immobilized cervical spine by unexperienced physicians: A randomized crossover manikin trial. Anaesthesiol Intensive Ther. 2017;49(4):274-282. doi: 10.5603/AIT.a2017.0047. Epub 2017 Sep 27.
citation: Truszewski Z, Krajewski P, Fudalej M, Smereka J, Frass M, Robak O, Nguyen B, Ruetzler K, Szarpak L. A comparison of a traditional endotracheal tube versus ETView SL in endotracheal intubation during different emergency conditions: A randomized, crossover cadaver trial. Medicine (Baltimore). 2016 Nov;95(44):e5170. doi: 10.1097/MD.0000000000005170.