Intubation During Spinal Immobilization

Not Applicable

Completed

• Conditions: Endotracheal Intubation
• Interventions: Device: Standard endotracheal tube; Device: C-MAC

• Registration Number: NCT02733536
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Study Start: 2016-12
• Primary Completion: 2017-02
• Study Completion: 2017-04
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Scenario A	C-MAC	manikin with normal standard airway
Scenario B	C-MAC	Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor.
Scenario C	Standard endotracheal tube	Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor
Scenario C	C-MAC	Cervical immobilization using a vacuum mattress (Ferno-Washington, Inc. Wilmington, OH, USA), applied to the manikin's neck by an instructor
Scenario A	Standard endotracheal tube	manikin with normal standard airway
Scenario B	Standard endotracheal tube	Cervical immobilization using a standard Patriot cervical extraction collar (Oessur Americas, Foothill Ranch, CA, USA), applied to the manikin's neck by an instructor.

Primary Outcome Measures

Name	Time	Method
Time required for successful intubation	1 day

Secondary Outcome Measures

Name	Time	Method
Cormack&Lehane grade	1 day	glottic view during intubation rate using Cormack\&Lehane grade
success rate of intubation attempt	1 day	success rate of first intubation attempt
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).

Trial Locations

Locations (1)

Medical University of Warsaw, Department of Emergency Medicine; 🇵🇱 Warsaw, Masovia, Poland