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

Cardiopulmonary Arrest Clinical Trial

Official title:

Improvement of Recovery of Spontaneous Circulation and Survival Using the Video-laryngoscopy for out-of Hospital Cardiac Arrest Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256019
• Other study ID #: CPRIntuVLvsDL
• 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
• 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

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

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