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

Primary Purpose

Respiratory Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
King Video Laryngoscope
traditional direct laryngoscopy (DL)
Sponsored by
Saint Vincent Hospital, Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring intubation, laryngoscopy, prehospital, emergency medical services

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • age < 18 years of age

Sites / Locations

  • Saint Vincent Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video Laryngoscopy

Direct Laryngoscopy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Success
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.

Full Information

First Posted
March 18, 2014
Last Updated
June 5, 2018
Sponsor
Saint Vincent Hospital, Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02208349
Brief Title
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
Official Title
King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis suggested additional enrollment would not change outcomes
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Vincent Hospital, Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
intubation, laryngoscopy, prehospital, emergency medical services

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video Laryngoscopy
Arm Type
Experimental
Arm Description
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.
Arm Title
Direct Laryngoscopy
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
King Video Laryngoscope
Intervention Description
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
Intervention Name(s)
traditional direct laryngoscopy (DL)
Primary Outcome Measure Information:
Title
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)
Description
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.
Time Frame
less than 24 hours, collected for the duration of the study (approximately 34 months)
Secondary Outcome Measure Information:
Title
Overall Success
Description
Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.
Time Frame
up to 24 hours, duration of the study (approximately 34 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients >= age 18 year of age undergoing ETI in the prehospital setting Exclusion Criteria: age < 18 years of age
Facility Information:
Facility Name
Saint Vincent Hospital
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16544
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3931512
Citation
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PubMed Identifier
15271750
Citation
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.
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PubMed Identifier
11145768
Citation
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.
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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King Video Laryngoscope Versus Direct Laryngoscopy for Prehospital Intubation: A Randomized Controlled Trial

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