Airway ManagementNCT03685968

King Vision® and GlideScope® in Difficult Airways

A study testing Video laryngoscopes in people with Airway Management, run by The University of Texas Health Science Center, Houston.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Airway Management
What is being tested?: Video laryngoscopes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 225 participants
Where: No sites listed yet
Study dates: 6 Mar 2013to 17 Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: A Comparison of the King Vision® Channeled, King Vision® Non-Channeled, and Glidescope® Video Intubation Systems in Patients at Risk for Difficult Intubation - A Pilot Study

Conditions: Airway Management
Being tested: Video laryngoscopes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Video laryngoscopesDevice
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.

Study groups in NCT03685968
Study group	Role	What they receive
Glidescope AVL	Experimental	Not described Receives: Device: Video laryngoscopes
King Vision Channeled VL	Experimental	Not described Receives: Device: Video laryngoscopes
King Vision Non-Channeled (Standard) VL	Experimental	Not described Receives: Device: Video laryngoscopes

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Measured: During laryngoscopy and endotracheal tube placement

Secondary outcomes (1)

First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL
Measured: During laryngoscopy and endotracheal tube placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201317 Dec 2015

First posted26 Sep 2018
Study start6 Mar 2013
Primary completion17 Nov 2015
Study completion17 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Airway ManagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03685968
Sponsor's protocol ID: HSC-MS-13-0024
Status last verified: Jan 2019
First submitted: 24 Sep 2018
Last updated: 8 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
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.
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management

All Airway Management trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of the King Vision® Channeled, King Vision® Non-Channeled, and Glidescope® Video Intubation Systems in Patients at Risk for Difficult Intubation - A Pilot Study
ClinicalTrials.gov ID: NCT03685968
Acronym / sponsor ID: HSC-MS-13-0024
Conditions: Airway Management
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: King Systems Corporation
Study start: 6 Mar 2013 (actual)
Primary completion: 17 Nov 2015 (actual)
Study completion: 17 Dec 2015 (actual)
First posted: 26 Sep 2018 (actual)
Results: Posted 4 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
Glidescope AVL	Experimental	Device: Video laryngoscopes
King Vision Channeled VL	Experimental	Device: Video laryngoscopes
King Vision Non-Channeled (Standard) VL	Experimental	Device: Video laryngoscopes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Mallampati I-II
Neck circumference < 43cm
Documented 'easy' intubation
Previous history of failed intubation and failed bag-mask ventilation
Under 18 years of age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Video laryngoscopesPatients 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.	Device	Glidescope AVL, King Vision Channeled VL, King Vision Non-Channeled (Standard) VL

Primary outcome

Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Time frame: During laryngoscopy and endotracheal tube placement
The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL

1 secondary outcome

First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL
Time frame: During laryngoscopy and endotracheal tube placement

Results and safety

Results posted to the registry on 4 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Glidescope AVL	75	75
King Vision Channeled VL	75	75
King Vision Non-Channeled (Standard) VL	75	75

Primary outcome: Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL

Time frame: During laryngoscopy and endotracheal tube placement. Count of participants. Unit: Participants

Measure	Glidescope AVL n = 75	King Vision Channeled VL n = 75	King Vision Non-Channeled (Standard) VL n = 75
Value	72	61	72

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Postoperatively in the PACU. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Glidescope AVL	0 of 75 (0%)	26 of 64 (40.6%)	0 of 75
King Vision Channeled VL	0 of 75 (0%)	23 of 65 (35.4%)	0 of 75
King Vision Non-Channeled (Standard) VL	0 of 75 (0%)	22 of 70 (31.4%)	0 of 75

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundHagberg 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.
BackgroundHagberg 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.
BackgroundHagberg 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.
Individual participant dataSharing planned: No

Related trials for Airway Management

Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Not yet recruiting
Video Laryngeal Mask SaCoVLM Versus LMA Supreme and Ambu AuraGain in Children
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Prediction of Difficult Mask Ventilation in Obese Population Undergoing Emergency Surgery
Difficult Airway Management

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carin A Hagberg, MD study chair

M.D. Anderson Cancer Center

Questions about this trial

What is this clinical trial studying?

A study testing Video laryngoscopes in people with Airway Management, run by The University of Texas Health Science Center, Houston.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL (time frame: During laryngoscopy and endotracheal tube placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03685968, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.