Pediatric Intubation

Cardiac Arrest Clinical Trial

— ETICPR  

Official title:

Comparison of the TruView PCD Video Laryngoscope and Macintosh Laryngoscope for Pediatric Tracheal Intubation by Novice Paramedics: A Randomized Crossover Simulation Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289872
• Other study ID #: TruView/01
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: January 21, 2015
• Start date: November 2014
• Est. completion date: December 2014

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

The aim of the study was to compare time and success rates of TruView PCD video laryngoscope and Macintosh laryngoscope for the pediatric emergency intubation with three airway scenarios in a standardized manikin model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• 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

• inexperienced in pediatric intubation paramedics

Exclusion Criteria:

• not meet the above criteria

• participants who had performed intubation in pediatric humans prior the trial or had previously TruView experience

Study Design

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Intubation

Intervention

Device:
• Macintosh Laryngoscope
Direct-Laryngoscopy
• TruView PCD Video laryngoscope
Video-Laryngoscopy

Locations

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

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	the time to intubation, defined as the time from insertion of the laryngoscope blade between the teeth to the first manual ventilation of the mannequin's lungs	1 day	No
Secondary	Success of intubation	success of the intubation attempt (i.e. tracheal or oesophageal placement of the tube) with was recorded when the success of the ventilation attempt was seen by the manikin's ventilation indicators.	1 day	No
Secondary	Cormack-Lehan scale	self reported Cormack-Lehan scale during intubation	1 day	No
Secondary	Dental compression	dental compression, with was assessed using a visual scale grading the pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3).	1day	No
Secondary	Ease of intubation (VAS)	To access subjective opinion about the difficulty of the each intubation method, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).	1 day	No