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
About this trial
This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring intubation, Cardiopulmonary Resuscitation
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
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
NCT ID
NCT03256019
First Posted
August 17, 2017
Last Updated
December 17, 2017
Sponsor
Konkuk University Medical Center
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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Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users
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