Comparison Four Intubation Devices

Intubation Clinical Trial

Official title:

Comparison of Tracheal Intubation Using the Miller, Macintosh, Phillips and Wis-Hipple Blades During Infant Resuscitation: A Randomized Crossover Simulation Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280213
• Other study ID #: ETI/2014/06
• Status: Completed
• Phase: N/A
• First received: October 28, 2014
• Last updated: January 31, 2015
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: International Institute of Rescue Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial Summary

Comparison of four laryngoscope blades (Miller, Macintosh, Phillips and Wis-Hipple) for infant intubation during resuscitation with and without chest compressions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• 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

• paramedics

• no clinical experience in infant intubation

Exclusion Criteria:

• not meet the above criteria

• wrist or low back diseases

• pregnancy.

Study Design

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

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• MIL
Direct laryngoscopy 1
• MAC
Direct laryngoscopy 2
• WIS
Direct laryngoscopy 3
• PHIL
Direct laryngoscopy 4

Locations

Country	Name	City	State
Poland	International Institute of Rescue Research and Education	Warsaw	Masovia

Sponsors (1)

Lead Sponsor	Collaborator
International Institute of Rescue Research and Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubation	time from insertion of the blade to the first manual ventilation of the manikin´s lungs. If time of intubation is over than 60 seconds, attempt was recognized as failure.	1 day	No
Secondary	Success of intubation	effectiveness of the first, second and third intubation attempts and overall effectiveness of intubation by participants using four intubation devices. If the examinee failed at all attempts, the case was excluded from the time calculations.	1 day	No
Secondary	Ease of Use	To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).	1 day	No
Secondary	POGO score	The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.	1 day	No
Secondary	Cormack-Lehane grading	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)	1 day	No
Secondary	dental compression	pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)	1 day	No