NCT02733536

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 5, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

2 months

First QC Date

April 5, 2016

Last Update Submit

July 25, 2017

Conditions

Endotracheal Intubation

Keywords

endotracheal intubationtraumaparamedic

Outcome Measures

Primary Outcomes (1)

  • Time required for successful intubation

    1 day

Secondary Outcomes (4)

  • success rate of intubation attempt

    1 day

  • Cormack&Lehane grade

    1 day

  • Dental Compression

    1 day

  • Ease of intubation

    1 day

Study Arms (3)

Scenario A

EXPERIMENTAL

manikin with normal standard airway

Device: Standard endotracheal tubeDevice: C-MAC

Scenario B

EXPERIMENTAL

Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor.

Device: Standard endotracheal tubeDevice: C-MAC

Scenario C

EXPERIMENTAL

Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor

Device: Standard endotracheal tubeDevice: C-MAC

Interventions

Standard endotracheal tubeDEVICE

1\) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube

Scenario AScenario BScenario C
C-MACDEVICE

C-MAC introduced with a h size 3 blade.

Scenario AScenario BScenario C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

Location

Related Publications (5)

  • 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.

    PMID: 26979260BACKGROUND

  • 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.

    PMID: 26494629BACKGROUND

  • 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.

    PMID: 28041757BACKGROUND

  • 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.

    PMID: 28953308DERIVED

  • 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.

    PMID: 27858851DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Łukasz Szarpak, PhD

    Medical University of Warsaw

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 11, 2016

Study Start

December 1, 2016

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

PL(1)