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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03256019
Other study ID # CPRIntuVLvsDL
Secondary ID
Status Completed
Phase N/A
First received August 17, 2017
Last updated December 17, 2017
Start date March 1, 2011
Est. completion date March 1, 2016

Study information

Verified date December 2017
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date March 1, 2016
Est. primary completion date March 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Konkuk University Medical Center

References & Publications (5)

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. — View 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. — View 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. — View Citation

Soar J, Nolan JP, Böttiger 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival with good neurologic outcome Survived patients who were conscious and able to perform independent activities of daily life (CPC1 or CPC2) 6 months after emergency department visit
Secondary ROSC Recovery of spontaneous circulation by successful resuscitation within 1 hour after emergency department visit
Secondary 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 within 1 hour after emergency department visit
Secondary complication Presence of chest compression interruption, esophageal intubation and dental injuries within 1 hour after emergency department visit
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