King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial

NCT02208349 | Terminated Results DMC

• 1 other identifier: LECOM Research Grant 2013
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare the first pass success rate of intubation between video assisted intubation and traditional direct visualization intubation in the field by Emergency Medical Service (EMS) professionals

Conditions

Respiratory Failure

Keywords

intubation, laryngoscopy, prehospital, emergency medical services

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful First Intubation Attempt (First Pass Attempt)

  Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.

  less than 24 hours, collected for the duration of the study (approximately 34 months)

Secondary Outcomes (1)

• Overall Success

  up to 24 hours, duration of the study (approximately 34 months)

Study Arms (2)

Video Laryngoscopy

EXPERIMENTAL

We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.

Device: King Video Laryngoscope

Direct Laryngoscopy

ACTIVE COMPARATOR

We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.

Device: traditional direct laryngoscopy (DL)

Interventions

King Video Laryngoscope DEVICE

We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.

Video Laryngoscopy

traditional direct laryngoscopy (DL) DEVICE

Direct Laryngoscopy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients \>= age 18 year of age undergoing ETI in the prehospital setting

You may not qualify if:

• age \< 18 years of age

Sponsors & Collaborators

• Saint Vincent Hospital, Pennsylvania: lead

Study Sites (1)

Saint Vincent Hospital

Erie, Pennsylvania, 16544, United States

Location

Related Publications (15)

• Pepe PE, Copass MK, Joyce TH. Prehospital endotracheal intubation: rationale for training emergency medical personnel. Ann Emerg Med. 1985 Nov;14(11):1085-92. doi: 10.1016/s0196-0644(85)80927-6.

  PMID: 3931512 BACKGROUND

• Wang HE, Mann NC, Mears G, Jacobson K, Yealy DM. Out-of-hospital airway management in the United States. Resuscitation. 2011 Apr;82(4):378-85. doi: 10.1016/j.resuscitation.2010.12.014. Epub 2011 Feb 1.

  PMID: 21288624 BACKGROUND

• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

  PMID: 15271750 BACKGROUND

• Katz SH, Falk JL. Misplaced endotracheal tubes by paramedics in an urban emergency medical services system. Ann Emerg Med. 2001 Jan;37(1):32-7. doi: 10.1067/mem.2001.112098.

  PMID: 11145768 BACKGROUND

• Jones JH, Murphy MP, Dickson RL, Somerville GG, Brizendine EJ. Emergency physician-verified out-of-hospital intubation: miss rates by paramedics. Acad Emerg Med. 2004 Jun;11(6):707-9. doi: 10.1197/j.aem.2003.12.026.

  PMID: 15175215 BACKGROUND

• Hubble MW, Brown L, Wilfong DA, Hertelendy A, Benner RW, Richards ME. A meta-analysis of prehospital airway control techniques part I: orotracheal and nasotracheal intubation success rates. Prehosp Emerg Care. 2010 Jul-Sep;14(3):377-401. doi: 10.3109/10903121003790173.

  PMID: 20507222 BACKGROUND

• Wang HE, Yealy DM. How many attempts are required to accomplish out-of-hospital endotracheal intubation? Acad Emerg Med. 2006 Apr;13(4):372-7. doi: 10.1197/j.aem.2005.11.001. Epub 2006 Mar 10.

  PMID: 16531595 BACKGROUND

• Lossius HM, Roislien J, Lockey DJ. Patient safety in pre-hospital emergency tracheal intubation: a comprehensive meta-analysis of the intubation success rates of EMS providers. Crit Care. 2012 Feb 11;16(1):R24. doi: 10.1186/cc11189.

  PMID: 22325973 BACKGROUND

• Warner KJ, Carlbom D, Cooke CR, Bulger EM, Copass MK, Sharar SR. Paramedic training for proficient prehospital endotracheal intubation. Prehosp Emerg Care. 2010 Jan-Mar;14(1):103-8. doi: 10.3109/10903120903144858.

  PMID: 19947874 BACKGROUND

• Carlson JN, Quintero J, Guyette FX, Callaway CW, Menegazzi JJ. Variables associated with successful intubation attempts using video laryngoscopy: a preliminary report in a helicopter emergency medical service. Prehosp Emerg Care. 2012 Apr-Jun;16(2):293-8. doi: 10.3109/10903127.2011.640764. Epub 2011 Dec 22.

  PMID: 22191806 BACKGROUND

• Guyette FX, Farrell K, Carlson JN, Callaway CW, Phrampus P. Comparison of video laryngoscopy and direct laryngoscopy in a critical care transport service. Prehosp Emerg Care. 2013 Apr-Jun;17(2):149-54. doi: 10.3109/10903127.2012.729128. Epub 2012 Dec 11.

  PMID: 23231426 BACKGROUND

• Sakles JC, Mosier J, Chiu S, Cosentino M, Kalin L. A comparison of the C-MAC video laryngoscope to the Macintosh direct laryngoscope for intubation in the emergency department. Ann Emerg Med. 2012 Dec;60(6):739-48. doi: 10.1016/j.annemergmed.2012.03.031. Epub 2012 May 5.

  PMID: 22560464 BACKGROUND

• Mosier JM, Stolz U, Chiu S, Sakles JC. Difficult airway management in the emergency department: GlideScope videolaryngoscopy compared to direct laryngoscopy. J Emerg Med. 2012 Jun;42(6):629-34. doi: 10.1016/j.jemermed.2011.06.007. Epub 2011 Sep 10.

  PMID: 21911279 BACKGROUND

• Wayne MA, McDonnell M. Comparison of traditional versus video laryngoscopy in out-of-hospital tracheal intubation. Prehosp Emerg Care. 2010 Apr-Jun;14(2):278-82. doi: 10.3109/10903120903537189.

  PMID: 20199237 BACKGROUND

• Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.

  PMID: 23812581 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Jestin Carlson
• Organization: St Vincent Hospital

jcarlson@svhs.org

8144525000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: August 5, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-06

Locations

US (1)