Intubation During Pediatric Resuscitation

Cardiac Arrest Clinical Trial

Official title:

Pediatric Tracheal Intubation Using Four Video-laryngoscopes and the Miller Laryngoscope With and Without Chest Compressions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02277015
• Other study ID #: ETI/2014/02
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 26, 2014
• Last updated: November 11, 2014
• Start date: October 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• 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 European Resuscitation Council (ERC) 2010 cardiopulmonary resuscitation (CPR) guidelines suggest that intubators should be able to secure the airway without interrupting chest compression. We examine the performance of the Berci-Kaplan DCI (BERCI), the GlideScope (GVL), the AirTraq, the Pentax AWS (Pentax) and the Miller laryngoscope (MIL) for endotracheal intubation (ETI) during pediatric resuscitation with and without chest compressions.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: November 2014
• Est. primary completion date: November 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

• minimum 1 year of work experience in emergency medicine

• experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

• not meet the above criteria

• wrist or low back diseases

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Endotracheal Intubation
• Heart Arrest
• Pediatric Manikin

Intervention

Device:
• Miller Laryngoscope
Direct Laryngoscopy
• The Berci-Kaplan DCI
Videolaryngoscope-1
• The AirTraq
Videolaryngoscope-2
• GlideScope GVL
Videolaryngoscope-3
• The Pentax AWS
Videolaryngoscope-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	Intubation Time	time in seconds required for a successful intubation attempt with the five different ETI devices	1 month	Yes
Secondary	Successful intubation	effectiveness of first, second, third intubation attempts and overall effectiveness intubation attempt using all intubation devices	1 month	Yes
Secondary	POGO score	self reported percentage og glottis opening (POGO) score	1 month	Yes
Secondary	VAS score	To assess subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (very easy) to 5 (very difficult).	1 month	Yes
Secondary	Preferred ETI device	participants were asked which method of ETI they would prefer in a real-life resuscitation.	1 month	Yes
Secondary	First Pass Attempt	Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.	1 month	Yes
Secondary	Overall Success	Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.	intraoperative	Yes