Intubation During Spinal Immobilization

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733536
• Other study ID #: 23.01.2017.IRB
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: July 25, 2017
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2017
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

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
• C-MAC
C-MAC introduced with a h size 3 blade.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw, Department of Emergency Medicine	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for successful intubation		1 day
Secondary	success rate of intubation attempt	success rate of first intubation attempt	1 day
Secondary	Cormack&Lehane grade	glottic view during intubation rate using Cormack&Lehane grade	1 day
Secondary	Dental Compression	the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)	1 day
Secondary	Ease of intubation	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).	1 day