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

NCT ID: NCT02208349

Last Updated: 2018-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-04-30

Brief Summary

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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

Detailed Description

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We will equip several local advanced life support ambulances with a low cost video laryngoscope for a total of 12 months. 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 including first pass intubation success, total success rate for intubation, and complications (need for surgical airway, rescue device, need to revert from KVL to DL, etc.). Please see the attached protocol page for additional details.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Video Laryngoscopy

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.

Group Type EXPERIMENTAL

King Video Laryngoscope

Intervention Type 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.

Direct Laryngoscopy

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.

Group Type ACTIVE_COMPARATOR

traditional direct laryngoscopy (DL)

Intervention Type DEVICE

Interventions

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King Video Laryngoscope

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.

Intervention Type DEVICE

traditional direct laryngoscopy (DL)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* age \< 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Vincent Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3931512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21288624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15271750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11145768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15175215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20507222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16531595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22325973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19947874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22191806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23231426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22560464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21911279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20199237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23812581 (View on PubMed)

Other Identifiers

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LECOM Research Grant 2013

Identifier Type: -

Identifier Source: org_study_id

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