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

Primary Purpose

Cardiopulmonary Arrest

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endotracheal Intubation
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring intubation, Cardiopulmonary Resuscitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    DL user

    VL user

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Survival with good neurologic outcome
    Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)

    Secondary Outcome Measures

    ROSC
    Recovery of spontaneous circulation by successful resuscitation
    total time to complete ETI from the beginning
    time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag
    complication
    Presence of chest compression interruption, esophageal intubation and dental injuries

    Full Information

    First Posted
    August 17, 2017
    Last Updated
    December 17, 2017
    Sponsor
    Konkuk University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03256019
    Brief Title
    Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users
    Official Title
    Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    March 1, 2016 (Actual)
    Study Completion Date
    March 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Konkuk University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiopulmonary Arrest
    Keywords
    intubation, Cardiopulmonary Resuscitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DL user
    Arm Type
    Active Comparator
    Arm Description
    Experienced emergency physicians who primarily used the direct laryngoscopy (DL) for endotracheal intubation during cardiopulmonary resuscitation.
    Arm Title
    VL user
    Arm Type
    Active Comparator
    Arm Description
    Experienced emergency physicians who primarily used the videolaryngoscopy (VL) for endotracheal intubation during cardiopulmonary resuscitation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endotracheal Intubation
    Intervention Description
    Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation
    Primary Outcome Measure Information:
    Title
    Survival with good neurologic outcome
    Description
    Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2)
    Time Frame
    6 months after emergency department visit
    Secondary Outcome Measure Information:
    Title
    ROSC
    Description
    Recovery of spontaneous circulation by successful resuscitation
    Time Frame
    within 1 hour after emergency department visit
    Title
    total time to complete ETI from the beginning
    Description
    time from the advancement of the blade into the patient's mouth to the delivery of the first successful ventilation using the bag
    Time Frame
    within 1 hour after emergency department visit
    Title
    complication
    Description
    Presence of chest compression interruption, esophageal intubation and dental injuries
    Time Frame
    within 1 hour after emergency department visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sang O Park, M.D,Ph.D
    Organizational Affiliation
    Department of Emergency Medicine, Konkuk University Medical center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26477701
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23321764
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19573949
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12565125
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23101777
    Citation
    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.
    Results Reference
    background

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