Intubation During Spinal Immobilization

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT02733536

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Intubation	Device: Standard endotracheal tube Device: C-MAC	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

C-MAC Compared to Direct Laryngoscopy in Patients With Immobilized Cervical Spine by Unexperienced Physicians: A Randomized Crossover Manikin Trial

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Scenario A manikin with normal standard airway	Device: Standard endotracheal tube 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 Device: C-MAC C-MAC introduced with a h size 3 blade.
Experimental: Scenario B 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 tube 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 Device: C-MAC C-MAC introduced with a h size 3 blade.
Experimental: Scenario C Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor	Device: Standard endotracheal tube 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 Device: C-MAC C-MAC introduced with a h size 3 blade.

Arm

Intervention/Treatment

Experimental: Scenario A

manikin with normal standard airway

Device: Standard endotracheal tube

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

Device: C-MAC

C-MAC introduced with a h size 3 blade.

Experimental: Scenario B

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 tube

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

Device: C-MAC

C-MAC introduced with a h size 3 blade.

Experimental: Scenario C

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

Device: Standard endotracheal tube

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

Device: C-MAC

C-MAC introduced with a h size 3 blade.

Outcome Measures

Primary Outcome Measures

Time required for successful intubation [1 day]

Secondary Outcome Measures

success rate of intubation attempt [1 day]
success rate of first intubation attempt
Cormack&Lehane grade [1 day]
glottic view during intubation rate using Cormack&Lehane grade
Dental Compression [1 day]
the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)
Ease of intubation [1 day]
To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Warsaw, Department of Emergency Medicine	Warsaw	Masovia	Poland	02-005

Sponsors and Collaborators

Medical University of Warsaw

Investigators

Principal Investigator: Łukasz Szarpak, PhD, Medical University of Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Łukasz Szarpak, Principal Investigator, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT02733536

Other Study ID Numbers:

23.01.2017.IRB

First Posted:

Apr 11, 2016

Last Update Posted:

Jul 27, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Łukasz Szarpak, Principal Investigator, Medical University of Warsaw

endotracheal intubation

trauma

paramedic

Study Results

No Results Posted as of Jul 27, 2017