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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02324465
Other study ID # 130470
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date October 2017

Study information

Verified date April 2019
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.


Description:

Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.

Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

- Patients who require rapid sequence induction and intubation or fiberoptic intubation.

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
King Vision Video Laryngoscope
Intubation via King Vision Video Laryngoscope
Glidescope Video Laryngoscope
Intubation via Glidescope Video Laryngoscope

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Adverse Events Notation of any injury to lips, teeth, soft tissue. during and immediately after procedure (approx 180 minutes)
Primary Time Until Intubation With Each Device time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture <100 seconds
Secondary Mean Pulse Oximetry Saturation Value Reading During Intubation <100 seconds
Secondary Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie. <100 seconds
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