King Vision® and GlideScope® in Difficult Airways

NCT ID: NCT03685968

Last Updated: 2019-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-06

Study Completion Date

2015-12-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Airway Management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glidescope AVL

Group Type EXPERIMENTAL

Video laryngoscopes

Intervention Type DEVICE

Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

King Vision Channeled VL

Group Type EXPERIMENTAL

Video laryngoscopes

Intervention Type DEVICE

Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

King Vision Non-Channeled (Standard) VL

Group Type EXPERIMENTAL

Video laryngoscopes

Intervention Type DEVICE

Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Video laryngoscopes

Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Over 18 years of age
* Mallampati III-IV
* Neck circumference \> 43cm
* Reduced mouth opening (\< 4cm) or 3 Finger breath's (patient's own)
* Thyromental distance \< 6cm

Exclusion Criteria

* Mallampati I-II
* Neck circumference \< 43cm
* Documented 'easy' intubation
* Previous history of failed intubation and failed bag-mask ventilation
* Under 18 years of age
* ASA IV
* Known unstable cervical spine injury
* Presentation for an emergency surgical procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King Systems Corporation

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carin A. Hagberg

Chief Academic Officer and Division Head of Anesthesiology, Critical Care, and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carin A Hagberg, MD

Role: STUDY_CHAIR

The University of Texas MD Anderson Cancer Center

References

Explore related publications, articles, or registry entries linked to this study.

Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501.

Reference Type BACKGROUND

Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420.

Reference Type BACKGROUND

Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212.

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-13-0024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.