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

Not Applicable

Terminated

• Conditions: Respiratory Failure
• Interventions: Device: King Video Laryngoscope; Device: traditional direct laryngoscopy (DL)

• Registration Number: NCT02208349
• Lead Sponsor: Saint Vincent Hospital, Pennsylvania

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 Timeline

• Study First Submitted: 2014-03-18
• Study Start: 2014-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2016-12
• Study Completion: 2017-04
• Results First Submitted: 2018-04-16
• Status Verified: 2018-06
• Results First Submitted QC: 2018-06-05
• Last Update Submitted: 2018-06-05
• Results First Posted: 2018-06-06
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

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

Exclusion Criteria

• age < 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Video Laryngoscopy	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.
Direct Laryngoscopy	traditional direct laryngoscopy (DL)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful First Intubation Attempt (First Pass Attempt)	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 Outcome Measures

Name	Time	Method
Overall Success	up to 24 hours, duration of the study (approximately 34 months)	Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.

Trial Locations

Locations (1)

Saint Vincent Hospital; 🇺🇸 Erie, Pennsylvania, United States