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CompletedNCT03256019Updated Dec 19, 2017

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

An interventional study of Endotracheal Intubation in Cardiopulmonary Arrest, sponsored by Konkuk University Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-19.

Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiopulmonary Arrest

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Keywords

  • intubation
  • Cardiopulmonary Resuscitation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who suffer sudden out-of hospital cardiac arrest

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (actual)

Study arms

  • Active comparator
    DL user

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

    Procedure: Endotracheal Intubation

  • Active comparator
    VL user

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

    Procedure: Endotracheal Intubation

Interventions

  • ProcedureEndotracheal Intubation

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

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What researchers measure

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)

    Time frame: 6 months after emergency department visit

Secondary outcomes

  1. ROSC

    Recovery of spontaneous circulation by successful resuscitation

    Time frame: within 1 hour after emergency department visit

  2. 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

    Time frame: within 1 hour after emergency department visit

  3. complication

    Presence of chest compression interruption, esophageal intubation and dental injuries

    Time frame: within 1 hour after emergency department visit

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Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 26477701 ↗
  • 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. PubMed 23321764 ↗
  • 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. PubMed 19573949 ↗
  • 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. PubMed 12565125 ↗
  • 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. PubMed 23101777 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03256019
Lead sponsor
Konkuk University Medical Center
Responsible party
Sang O, Park (Associate Professor, Konkuk University Medical Center) — Principal investigator
First posted
Aug 21, 2017
Start date
Mar 1, 2011
Primary completion
Mar 1, 2016
Completion
Mar 1, 2016
Last update
Dec 19, 2017

Study contacts

Sang O Park, M.D,Ph.D
principal investigator · Department of Emergency Medicine, Konkuk University Medical center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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