NCT03252886

Brief Summary

This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

4 years

First QC Date

August 14, 2017

Last Update Submit

December 16, 2017

Conditions

Keywords

intubationCardiopulmonary Resuscitationneck injury

Outcome Measures

Primary Outcomes (1)

  • First attempt successful ETI

    Successfully insertion of endotracheal tube into trachea at first attempt

    within 1 hour after emergency department visit

Secondary Outcomes (2)

  • the time to complete ETI from the beginning

    within 1 hour after emergency department visit

  • Occurance of complication

    within 1 hour after emergency department visit

Study Arms (2)

DL user

ACTIVE COMPARATOR

Experienced emergency physicians who primarily use the direct laryngoscopy (DL) for endotracheal intubation during cardio-pulmonary resuscitation.

Procedure: Endotracheal Intubation

VL user

ACTIVE COMPARATOR

Experienced emergency physicians who primarily use the videolaryngoscopy (VL) for endotracheal intubation during cardio-pulmonary resuscitation.

Procedure: Endotracheal Intubation

Interventions

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:

  • Multiple trauma patients with suspected neck injuries
  • Arrest Patients

You may not qualify if:

  • Case of requesting the do-not attempt resuscitation before ETI
  • already intubated case before arrival to hospital
  • Cardiac arrest from non-traumatic causes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Emergency Medicine, Konkuk University Medical center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Heart ArrestNeck Injuries

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Sang O Park, M.D,Ph.D

    School of Medicine, Konkuk University

    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 14, 2017

First Posted

August 17, 2017

Study Start

March 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations