Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03256019
Collaborator
(none)
600
2
60

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endotracheal Intubation
N/A

Detailed Description

Endotracheal intubation (ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome the problems of DL.

This study tried to compare the recovery of spontaneous circulation (ROSC) and survival discharge between use of standard device (DL) and VL in a real clinical setting. In addition, this study also compare the first pass success rate of ETI,speed of ETI, incidences of complications, and chest compression interruptions during cardiopulmonary resuscitation between both device users.

Study Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient
Actual Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DL user

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

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

Active Comparator: VL user

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

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

Outcome Measures

Primary Outcome Measures

  1. Survival with good neurologic outcome [6 months after emergency department visit]

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

Secondary Outcome Measures

  1. ROSC [within 1 hour after emergency department visit]

    Recovery of spontaneous circulation by successful resuscitation

  2. total time to complete ETI from the beginning [within 1 hour after emergency department visit]

    time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag

  3. complication [within 1 hour after emergency department visit]

    Presence of chest compression interruption, esophageal intubation and dental injuries

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who suffer sudden out-of hospital cardiac arrest
Exclusion Criteria:
  • Cardiac arrests from multiple trauma

  • Cases of requesting the do-not attempt resuscitation before ETI

  • Intubated cases before arrival to emergency department

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Konkuk University Medical Center

Investigators

  • Principal Investigator: Sang O Park, M.D,Ph.D, Department of Emergency Medicine, Konkuk University Medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sang O, Park, Associate Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT03256019
Other Study ID Numbers:
  • CPRIntuVLvsDL
First Posted:
Aug 21, 2017
Last Update Posted:
Dec 19, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sang O, Park, Associate Professor, Konkuk University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2017