Endotracheal Intubation in Prehospital Scenario

Endotracheal Intubation Clinical Trial

Official title:

Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681835
• Other study ID #: 02.007.1MR
• Status: Completed
• Phase: N/A
• First received: February 10, 2016
• Last updated: March 8, 2016
• Start date: February 2016
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• give voluntary consent to participate in the study

• maximum 1 year of work experience in medicine

• minimum 50 clinical intubations

• paramedics

Exclusion Criteria:

• not meet the above criteria

• wrist or low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Device:
• C-MAC laryngoscope
Intubation performed using C-MAC laryngoscope
• Macintosh laryngoscope
Intubation performed using laryngoscope with Macintosh 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for successful intubation		1 day	No
Secondary	success rate of intubation attempt	success rate of first, second and third intubation attempt	1 day	No
Secondary	cumulative success ratios related to time	cumulative success ratio was counted as percentage of successful intubations in time intervals in all scenarios	1 day	No
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	No
Secondary	Cormack&Lehane grade	glottic view during intubation rate using Cormack&Lehane grade	1 day	No
Secondary	Dental Compression	the severity of the potential dental trauma was calculated based on previously described modified grading scale (Svoldelli, 2009)	1 day	No