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Clinical Trials/NCT02208349
NCT02208349TerminatedNot Applicable

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

Saint Vincent Hospital, Pennsylvania2 sites in 1 country83 target enrollmentStarted: April 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
83
Locations
2
Primary Endpoint
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • age < 18 years of age

Arms & Interventions

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.

Intervention: King Video Laryngoscope (Device)

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.

Intervention: traditional direct laryngoscopy (DL) (Device)

Outcomes

Primary Outcomes

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

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

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 Outcomes

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

Investigators

Sponsor
Saint Vincent Hospital, Pennsylvania
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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