NCT03256019

Brief Summary

This is a clinical study based on the analysis of video-clip data of cardiopulmonary resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between 2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

5 years

First QC Date

August 17, 2017

Last Update Submit

December 17, 2017

Conditions

Cardiopulmonary Arrest

Keywords

intubationCardiopulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

  • Survival with good neurologic outcome

    Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)

    6 months after emergency department visit

Secondary Outcomes (3)

  • ROSC

    within 1 hour after emergency department visit

  • total time to complete ETI from the beginning

    within 1 hour after emergency department visit

  • complication

    within 1 hour after emergency department visit

Study Arms (2)

DL user

ACTIVE COMPARATOR

Experienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation.

Procedure: Endotracheal Intubation

VL user

ACTIVE COMPARATOR

Experienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation.

Procedure: Endotracheal Intubation

Interventions

Endotracheal IntubationPROCEDURE

Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation

DL userVL user

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who suffer sudden out-of hospital cardiac arrest

You may not qualify if:

  • Cardiac arrests from multiple trauma
  • Cases of requesting the do-not attempt resuscitation before ETI
  • Intubated cases before arrival to emergency department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.

    PMID: 26477701BACKGROUND

  • Hasegawa K, Hiraide A, Chang Y, Brown DF. Association of prehospital advanced airway management with neurologic outcome and survival in patients with out-of-hospital cardiac arrest. JAMA. 2013 Jan 16;309(3):257-66. doi: 10.1001/jama.2012.187612.

    PMID: 23321764BACKGROUND

  • Wang HE, Simeone SJ, Weaver MD, Callaway CW. Interruptions in cardiopulmonary resuscitation from paramedic endotracheal intubation. Ann Emerg Med. 2009 Nov;54(5):645-652.e1. doi: 10.1016/j.annemergmed.2009.05.024. Epub 2009 Jul 2.

    PMID: 19573949BACKGROUND

  • Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.

    PMID: 12565125BACKGROUND

  • Rothfield KP, Russo SG. Videolaryngoscopy: should it replace direct laryngoscopy? a pro-con debate. J Clin Anesth. 2012 Nov;24(7):593-7. doi: 10.1016/j.jclinane.2012.04.005.

    PMID: 23101777BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Sang O Park, M.D,Ph.D

    Department of Emergency Medicine, Konkuk University Medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

March 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share