Comparison Four Intubation Devices

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: MIL; Device: MAC; Device: WIS; Device: PHIL

• Registration Number: NCT02280213
• Lead Sponsor: International Institute of Rescue Research and Education

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-31
• Study Start: 2014-11
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-31
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intubation with chest compression	MIL	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.
Intubation with chest compression	PHIL	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.
Intubation without chest compression	WIS	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Intubation without chest compression	MIL	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Intubation without chest compression	MAC	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Intubation without chest compression	PHIL	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) during resuscitation without chest compressions.
Intubation with chest compression	MAC	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.
Intubation with chest compression	WIS	Endotracheal intubation of infant mannikin using different laryngoscope blades (MAC, MIL, PHIL, WIS) with uninterrupted chest compressions. Chest compressions with the two thumb-encircling hands technique were performed by the same Basic Life Support (BLS) instructor at a rate of 100 compressions per minute and at a depth of about 1.5 inches according to the European Resuscitation Council guidelines of 2010 year.

Primary Outcome Measures

Name	Time	Method
Time to intubation	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Success of intubation	1 day	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.
Ease of Use	1 day	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).
POGO score	1 day	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.
Cormack-Lehane grading	1 day	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
dental compression	1 day	pressure applied on the upper teeth (n=none, mild=1, moderate=2, severe=3)

Trial Locations

Locations (1)

International Institute of Rescue Research and Education; 🇵🇱 Warsaw, Masovia, Poland